Solid State X-Ray Imager (Flat Panel/Digital Imager)
FDA product code MQB · Class II (moderate risk) · 21 CFR 892.1680 · Radiology
424510(k) clearances
0PMA approvals
188recalls
Manufacturers
- Rayence Co., Ltd. 29
- Canon, Inc. 27
- DRTECH Corporation 18
- Iray Technology Taicang , Ltd. 17
- Carestream Health, Inc. 15
- Vieworks Co., Ltd. 14
- Agfa Healthcare N.V. 13
- Konica Minolta Medical & Graphic, Inc. 13
- Konica Minolta, Inc. 12
- Careray Digital Medical System Co., Ltd. 10
- Fujifilm Medical System U.S.A., Inc. 10
- Imaging Dynamics Company , Ltd. 10
- Lg Electronics.Inc 9
- Philips Medical Systems Dmc GmbH 8
- AGFA Corp. 7
- New Medical Co., Ltd. 6
- Varex Imaging Corporation 6
- Canon Inc. -Medical Equipment Group 6
- Fujifilm Medical Systems U.S.A, Inc. 6
- Canon USA, Inc. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
| K244010 | ExamVue ApexMQB · Traditional | Jpi Healthcare Co, Ltd. | 02/24/2025SE |
| K243171 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 12/19/2024SE |
| K241319 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 11/21/2024SE |
| K241125 | Vivix-S 1751SMQB · Traditional | Vieworks Co., Ltd. | 11/15/2024SE |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROCMQB · Traditional | Prognosys Medical Systems Private Limited | 11/12/2024SE |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)MQB · Traditional | Aspen Imaging Healthcare, Inc. | 11/07/2024SE |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)MQB · Traditional | Rayence Co., Ltd. | 09/09/2024SE |
| K240371 | 0909FCC, 0909FCC-HSMQB · Special | Rayence Co., Ltd. | 03/07/2024SE |
| K232082 | Expd 4343SMQB · Special | DRTECH Corporation | 02/13/2024SE |
| K232753 | Expd 4343D; Expd 3643DMQB · Special | DRTECH Corporation | 11/16/2023SE |
| K230918 | MasterX 800 SeriesMQB · Traditional | Medicatech USA | 09/01/2023SE |
| K232058 | YosemiteView 4343W/YosemiteView 3643WMQB · Special | Careray Digital Medical Technology Co., Ltd. | 08/03/2023SE |
| K231959 | Expd 4357; Expd 4357PMQB · Special | DRTECH Corporation | 08/01/2023SE |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4MQB · Traditional | Radmedix, LLC | 07/12/2023SE |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFMQB · Special | Rayence Co., Ltd. | 06/21/2023SE |
| K223930 | A1417MCW/A1717MCW/F1417MCWMQB · Traditional | H&abyz Co., Ltd. | 03/06/2023SE |
| K230175 | Digital Radiography CXDI-CS01MQB · Special | Canon, Inc. | 02/15/2023SE |
| K230059 | Digital Flat Panel DetectorMQB · Special | Ray Imaging Technology (Haining) Limited | 02/03/2023SE |
| K223546 | 14HQ721G-BMQB · Traditional | Lg Electronics.Inc | 01/27/2023SE |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X)MQB · Special | Careray Digital Medical Technology Co., Ltd. | 12/30/2022SE |
| K223009 | Wireless/Wired X-Ray Flat Panel DetectorsMQB · Traditional | Allengers Medical Systems Limited | 11/27/2022SE |
| K223124 | Expd 86P, Expd 86PG, Expd 129P, Expd 129PGMQB · Special | DRTECH Corporation | 11/18/2022SE |
| K223267 | SKR 3000MQB · Special | Konica Minolta, Inc. | 11/17/2022SE |
| K222886 | Mercu 1717VMQB · Special | Iray Technology Taicang , Ltd. | 10/20/2022SE |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | Canon, Inc. | 10/17/2022SE |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special | Canon, Inc. | 09/29/2022SE |
| K222661 | Digital Radiography CXDI-CS01MQB · Special | Canon, Inc. | 09/27/2022SE |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB)MQB · Traditional | Vieworks Co., Ltd. | 09/13/2022SE |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF)MQB · Traditional | Careray Digital Medical Technology Co., Ltd. | 08/01/2022SE |
| K221461 | 10HQ701G-BMQB · Traditional | Lg Electronics.Inc | 07/22/2022SE |
| K221394 | 14HQ701G-BMQB · Traditional | Lg Electronics.Inc | 07/22/2022SE |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)MQB · Traditional | Vieworks Co., Ltd. | 07/20/2022SE |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | Canon, Inc. | 07/15/2022SE |
| K221434 | 17HQ701G-BMQB · Traditional | Lg Electronics.Inc | 07/13/2022SE |
| K221714 | Flat Panel DetectorMQB · Special | Iray Technology Taicang , Ltd. | 06/29/2022SE |
| K221345 | Wireless Digital Flat Panel DetectorMQB · Special | Iray Technology Taicang , Ltd. | 06/16/2022SE |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special | Canon, Inc. | 06/14/2022SE |
| K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FGMQB · Special | Radisen Co., Ltd. | 05/13/2022SE |
| K220559 | 17HQ901G-BMQB · Traditional | Lg Electronics.Inc | 05/05/2022SE |
| K220536 | Digital flat panel detectorMQB · Traditional | Iray Technology Taicang , Ltd. | 04/28/2022SE |
| K220510 | Yushan X-Ray Flat Panel Detector with DROCMQB · Traditional | Innocare Optoelectronics Corp. | 04/14/2022SE |
| K220668 | Wireless Digital Flat Panel DetectorMQB · Special | Iray Technology Taicang , Ltd. | 04/01/2022SE |
| K213646 | Focus HD 35 DetectorMQB · Special | Iray Technology Taicang , Ltd. | 03/29/2022SE |
| K213529 | Focus HD 43 DetectorMQB · Special | Iray Technology Taicang , Ltd. | 03/29/2022SE |
| K214044 | 14HQ901G-BMQB · Traditional | Lg Electronics.Inc | 02/16/2022SE |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | Canon, Inc. | 02/04/2022SE |
| K213908 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 01/31/2022SE |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB · Traditional | Canon, Inc. | 01/24/2022SE |
| K214030 | Universal DR 1748MQB · Traditional | Konica Minolta Healthcare Americas, Inc. | 01/21/2022SE |
| K213307 | Eclipse II with Smart Noise CancellationMQB · Traditional | Carestream Health, Inc. | 01/14/2022SE |
| K213469 | ValoryMQB · Traditional | Agfa N.V. | 11/18/2021SE |
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)MQB · Special | H&abyz Co., Ltd. | 11/15/2021SE |
| K212753 | 0909FCB, 1212FCAMQB · Special | Rayence Co., Ltd. | 10/18/2021SE |
| K212269 | Intelligent NRMQB · Traditional | Canon, Inc. | 09/17/2021SE |
| K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1MQB · Special | Canon, Inc. | 09/09/2021SE |
| K212051 | RFA-1717DIG, RFA-1717DICMQB · Traditional | Astel, Inc. | 08/25/2021SE |
| K210619 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 08/24/2021SE |
| K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFMQB · Traditional | Pzmedical Technology Co., Ltd. | 08/23/2021SE |
| K211790 | DX-D Imaging Package with XD DetectorsMQB · Traditional | Agfa N.V. | 07/30/2021SE |
| K211542 | Primo SMQB · Traditional | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 07/09/2021SE |
| K211108 | Prudent 1717, Prudent 1417, Prudent 1212MQB · Traditional | Pixxgen Corporation | 06/04/2021SE |
| K210919 | AcuityDReMQB · Traditional | Radmedix, LLC | 04/30/2021SE |
| K210985 | 1717FCCMQB · Special | Rayence Co., Ltd. | 04/28/2021SE |
| K210988 | Yushan X-Ray Flat Panel Detector with DROCMQB · Traditional | Innocare Optoelectronics Corp. | 04/21/2021SE |
| K202441 | Eclipse II with Smart Noise CancellationMQB · Traditional | Carestream Health, Inc. | 04/02/2021SE |
| K203703 | I-Q ViewMQB · Traditional | First Source, Inc. | 03/24/2021SE |
| K203188 | AddMQB · Traditional | H&abyz Co., Ltd. | 03/12/2021SE |
| K210316 | Mars 1417X Wireless Digital Flat Panel DetectorMQB · Special | Iray Technology Taicang , Ltd. | 03/03/2021SE |
| K210314 | Mars1717X Wireless Digital Flat Panel DetectorMQB · Special | Iray Technology Taicang , Ltd. | 03/02/2021SE |
| K202995 | X-ray Flat Panel Detectors/CareView 3600RFMQB · Traditional | Careray Digital Medical System Co., Ltd. | 02/19/2021SE |
| K203849 | General Radiography CXDI-CS01MQB · Special | Canon, Inc. | 01/26/2021SE |
| K203159 | Lux 35 DetectorMQB · Special | Carestream Health | 12/02/2020SE |
| K202722 | 1212FCAMQB · Special | Rayence Co., Ltd. | 10/26/2020SE |
| K201528 | Yushan X-Ray Flat Panel Detector with DROCMQB · Traditional | Innocare Optoelectronics Corp. | 10/11/2020SE |
| K202564 | DigitalDiagnost C90MQB · Special | Philips Medical Systems Dmc GmbH | 09/30/2020SE |
| K201591 | Flat Panel DetectorMQB · Traditional | Ka Imaging, Inc. | 09/03/2020SE |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)MQB · Special | Careray Digital Medical System Co., Ltd. | 08/07/2020SE |
| K201796 | 1717SCV, 1717SGVMQB · Special | Rayence Co., Ltd. | 07/23/2020SE |
| K201503 | Edge Air(1417) Digital Flat Panel X-ray DetectorMQB · Special | Osko, Inc. | 06/29/2020SE |
| K201247 | Intraoral SensorMQB · Traditional | Dentium Co., Ltd (Ict Branch) | 06/10/2020SE |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)MQB · Special | Iray Technology Taicang , Ltd. | 05/12/2020SE |
| K201058 | Accuvue+MQB · Special | Radmedix, LLC | 05/06/2020SE |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…MQB · Special | Iray Technology Taicang , Ltd. | 05/01/2020SE |
| K200787 | BSD3543WMQB · Special | Bontech Co., Ltd. | 04/23/2020SE |
| K200668 | DR-ID 1200SDK SystemMQB · Special | Fujifilm Corporation | 04/10/2020SE |
| K200622 | Focus 43C detector, TRIMAX 43C detectorMQB · Special | Iray Technology Taicang , Ltd. | 04/01/2020SE |
| K200418 | Vivix-S VWMQB · Traditional | Vieworks Co., Ltd. | 03/18/2020SE |
| K192894 | Vita Flex CR System with LLIMQB · Special | Carestream Health, Inc. | 02/18/2020SE |
| K193644 | E-Com DR-2000 DRMQB · Traditional | Livermoretech, Inc. | 02/14/2020SE |
| K200018 | HAD1717MCMQB · Traditional | H&Abyz | 01/31/2020SE |
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp)MQB · Special | Varex Imaging Corporation | 12/20/2019SE |
| K193173 | CareView 1800LeMQB · Special | Careray Digital Medical System Co., Ltd. | 12/13/2019SE |
| K193031 | Expd 4343P, Expd 3643PMQB · Special | DRTECH Corporation | 11/22/2019SE |
| K193017 | Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPMQB · Special | DRTECH Corporation | 11/22/2019SE |
| K192932 | FDR D-EVO III flat panel detector systemMQB · Special | Fujifilm Corporation | 11/12/2019SE |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessMQB · Special | Canon, Inc. | 11/07/2019SE |
| K192440 | FDR SE LiteMQB · Traditional | Fujifilm Corporation | 11/01/2019SE |
| K192512 | Focus 35C Detector, Trimax 35C DetectorMQB · Special | Iray Technology Taicang , Ltd. | 10/16/2019SE |
| K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGMQB · Special | DRTECH Corporation | 10/03/2019SE |
| K191939 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 08/29/2019SE |
| K191645 | SKR 4000MQB · Traditional | Konica Minolta, Inc. | 08/16/2019SE |
| K190611 | Vivix-S 1751SMQB · Traditional | Vieworks Co., Ltd. | 04/08/2019SE |
| K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor PanelMQB · Traditional | Pixxgen Corporation | 04/04/2019SE |
| K190368 | Enhanced Feature Software Pack CXDI SeriesMQB · Special | Canon, Inc. | 03/13/2019SE |
| K190311 | BIOK7600 Flat Panel DetectorMQB · Traditional | Biokinemetrics, Inc. | 03/13/2019SE |
| K190300 | BIOK7600W Wireless Flat Panel DetectorMQB · Traditional | Biokinemetrics, Inc. | 03/13/2019SE |
| K190146 | Nexus DR Digital X-ray Imaging SystemMQB · Special | Varex Imaging Corporation | 03/08/2019SE |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 DetectorsMQB · Traditional | Carestream Health, Inc. | 02/08/2019SE |
| K183474 | Carestream DRX-1 System with DRX Core DetectorsMQB · Special | Carestream Health, Inc. | 01/16/2019SE |
| K182973 | DigitalDiagnost C90MQB · Traditional | Philips Medical Systems Dmc GmbH | 01/11/2019SE |
| K183713 | Wireless Digital Flat DetectorMQB · Special | Iray Technology Taicang , Ltd. | 01/09/2019SE |
| K183422 | Wireless Digital Flat Panel DetectorMQB · Special | Iray Technology Taicang , Ltd. | 01/09/2019SE |
| K182688 | SKR 3000MQB · Special | Konica Minolta, Inc. | 12/18/2018SE |
| K183286 | 17HK701G-WMQB · Traditional | Lg Electronics.Inc | 12/07/2018SE |
| K183212 | Nexus DR Digital X-ray Imaging System with stitchingMQB · Special | Varex Imaging Corporation | 12/07/2018SE |
| K182348 | 14HK701G-WMQB · Traditional | Lg Electronics.Inc | 10/18/2018SE |
| K182551 | Wireless Digital Flat Panel DetectorMQB · Traditional | Iray Technology Taicang , Ltd. | 10/17/2018SE |
| K182550 | Wireless Digital Flat Panel DetectorMQB · Traditional | Iray Technology Taicang , Ltd. | 10/17/2018SE |
| K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsMQB · Traditional | Pixxgen Corporation | 10/04/2018SE |
| K181631 | GR40CWMQB · Traditional | Samsung Electronics Co., Ltd. | 07/20/2018SE |
| K181565 | Aquarius 8600 Digital Radiography SensorMQB · Special | Biokinemetrics, Inc. | 07/13/2018SE |
| K181526 | XRpad2 4343 HWC-M Flat Panel DetectorMQB · Special | Varex Imaging Corporation | 07/03/2018SE |
| K180809 | Eclipse IIMQB · Traditional | Carestream Health, Inc. | 06/21/2018SE |
| K180989 | PEDRA-17F Digital Flat Panel X-ray DetectorMQB · Traditional | Radisen, Inc. | 06/13/2018SE |
| K180332 | 17HK700G-WMQB · Traditional | Lg Electronics | 06/08/2018SE |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsMQB · Traditional | Pixxgen Corporation | 05/24/2018SE |
| K181003 | Vivix-S 1717VMQB · Traditional | Vieworks Co., Ltd. | 05/15/2018SE |
| K180667 | SmartGridMQB · Special | Carestream Health, Inc. | 04/13/2018SE |
| K171270 | Digital Radiography CXDI-410C WirelessMQB · Traditional | Canon, Inc. | 11/17/2017SE |
| K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCIMQB · Special | Imaging Dynamics Company , Ltd. | 11/09/2017SE |
| K172124 | Televere Podiatry Digital Imaging SystemMQB · Traditional | Televere Systems | 11/09/2017SE |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)MQB · Special | Varex Imaging Corporation | 10/24/2017SE |
| K172784 | DX-D Imaging PackageMQB · Traditional | Agfa Healthcare N.V. | 10/13/2017SE |
| K172435 | Galaxy R Digital Radiography UpgradeMQB · Traditional | Medien International Co, Ltd. | 10/13/2017SE |
| K172793 | SKR 3000MQB · Special | Konica Minolta, Inc. | 10/12/2017SE |
| K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TGMQB · Special | Imaging Dynamics Company , Ltd. | 10/12/2017SE |
| K172682 | Edge Digital Flat Panel X-ray DetectorMQB · Traditional | Osko, Inc. | 10/06/2017SE |
| K172681 | Edge Air Digital Flat Panel X-ray DetectorMQB · Traditional | Osko, Inc. | 10/06/2017SE |
| K171175 | Aquarius 8600 1417WCMQB · Special | Imaging Dynamics Company , Ltd. | 10/05/2017SE |
| K172581 | CareView 1800Cw X-ray Flat Panel DetectorsMQB · Special | Careray Digital Medical System Co., Ltd. | 09/26/2017SE |
| K171716 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 08/25/2017SE |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsMQB · Traditional | Philips Medical Systems Dmc GmbH | 07/07/2017SE |
| K170480 | Models 3543A, 4343A, 2929A and A843BMQB · Traditional | Shanghai PZ Medical Technolgoy Co., Ltd. | 07/07/2017SE |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…MQB · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 06/30/2017SE |
| K171485 | BSD4343R Digital Flat Panel X-ray DetectorMQB · Special | Bontech, Inc. | 06/21/2017SE |
| K171418 | 1417WCC_127um and1417WCC_140umMQB · Special | Rayence Co., Ltd. | 06/12/2017SE |
| K171417 | 1417WGC_127um and 1417WGC_140umMQB · Special | Rayence Co., Ltd. | 06/12/2017SE |
| K171420 | 1717SCC_127um and 1717SCC_140umMQB · Special | Rayence Co., Ltd. | 06/09/2017SE |
| K171419 | 1717SGC_127um and 1717SGC_140umMQB · Special | Rayence Co., Ltd. | 06/09/2017SE |
| K171138 | Nexus DR Digital X-ray Imaging SystemMQB · Special | Varex Imaging Corporation | 05/17/2017SE |
| K171137 | Evs 2430W, Evs 2430GWMQB · Special | DRTECH Corporation | 05/15/2017SE |
| K171085 | GMR40MQB · Traditional | Neurologica Corporation, A Subsidiary OF | 05/11/2017SE |
| K170975 | Televere Digital Imaging SystemMQB · Traditional | Televere Systems | 05/01/2017SE |
| K163157 | SmartGridMQB · Traditional | Carestream Health | 03/21/2017SE |
| K170332 | Digital Radiography CXDI-710C Wireless, Digital Radiography CXDI-810C WirelessMQB · Traditional | Canon, Inc. | 03/01/2017SE |
| K170202 | Aquarius 8600MQB · Special | Imaging Dynamics Company , Ltd. | 02/22/2017SE |
| K170113 | pixium 4343RCEMQB · Special | Philips Medical Systems Dmc GmbH | 02/09/2017SE |
| K163703 | Vivix-S 1417NMQB · Traditional | Vieworks Co., Ltd. | 02/08/2017SE |
| K162909 | CSX-30 Flat Panel DetectorMQB · Traditional | Canon, Inc. Medical Equipment Group | 01/27/2017SE |
| K162555 | Evs 4343, Evs 4343GMQB · Special | DRTECH Corporation | 12/21/2016SE |
| K162344 | Innolux RicMQB · Traditional | Innolux Corporation | 12/20/2016SE |
| K161730 | Wireless Digital Flat Panel DetectorMQB · Traditional | Iray Technology (Shanghai) , Ltd. | 12/08/2016SE |
| K162552 | Evs 3643, Evs 3643GMQB · Special | DRTECH Corporation | 12/02/2016SE |
| K163019 | CareView 750Cw/750C X-ray Flat Panel DetectorsMQB · Special | Careray Digital Medical System Co., Ltd. | 12/01/2016SE |
| K160143 | ClearVision ExamVue Flat Panel DetectorMQB · Traditional | Jpi Healthcare, Inc. | 10/28/2016SE |
| K162487 | BSD3543 Digital Flat Panel X-ray DetectorMQB · Special | Bontech, Inc. | 10/14/2016SE |
| K162519 | 1717WCC / 1717WGCMQB · Special | Rayence Co., Ltd. | 10/06/2016SE |
| K162518 | 1012WCC, 1012WGCMQB · Special | Rayence Co., Ltd. | 10/06/2016SE |
| K162504 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 10/03/2016SE |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…MQB · Traditional | Agfa Healthcare N.V. | 09/22/2016SE |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorMQB · Special | Perkinelmer, Inc. | 09/08/2016SE |
| K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)MQB · Traditional | Varian Medical Systems, X-Ray Products-Infimed | 09/06/2016SE |
| K162178 | CareView 1500P X-ray Flat Panel DetectorsMQB · Special | Careray Digital Medical System Co., Ltd. | 09/01/2016SE |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorMQB · Special | Perkinelmer, Inc. | 09/01/2016SE |
| K153312 | Scatter Correction for Cxdi SeriesMQB · Traditional | Canon, Inc. | 06/28/2016SE |
| K160204 | BSD4343 Digital Flat Panel X-ray DetectorMQB · Traditional | Bontech, Inc. | 06/09/2016SE |
| K160810 | ViZion DR + WirelessMQB · Traditional | Viztek, LLC | 05/20/2016SE |
| K153464 | FDR D-EVO flat Panel Detector SystemMQB · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 04/08/2016SE |
| K153710 | Tuxedo Digital Dental SensorMQB · Traditional | Led Dental, Inc. | 03/18/2016SE |
| K152894 | Vivix-S 1717NMQB · Traditional | Vieworks Co., Ltd. | 02/26/2016SE |
| K152855 | Vivix-S 1012NMQB · Traditional | Vieworks Co., Ltd. | 02/26/2016SE |
| K153492 | CareView 1800LMQB · Special | Careray Digital Medical System Co., Ltd. | 12/24/2015SE |
| K153318 | Philips Eleva Workspot with SkyFlowMQB · Special | Philips Medical Systems Dmc GmbH | 12/22/2015SE |
| K153401 | GR40CWMQB · Traditional | Samsung Electronics Co., Ltd. | 12/21/2015SE |
| K152639 | DR 600MQB · Traditional | Agfa Healthcare N.V. | 12/11/2015SE |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 DetectorsMQB · Traditional | Carestream Health, Inc. | 11/25/2015SE |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsMQB · Special | Careray Digital Medical System Co., Ltd. | 11/10/2015SE |
| K152151 | Atal 9MQB · Special | Atlaim Corporation | 11/10/2015SE |
| K152138 | FDR D-EVO GL Flat Panel Detector SystemMQB · Traditional | Fujifilm Medical System U.S.A., Inc. | 11/05/2015SE |
| K151942 | Evs 3643MQB · Traditional | DRTECH Corporation | 10/21/2015SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2354-2026 Class II | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent… | Philips North America Llc | 05/01/2026Open, Classified |
| Z-0465-2026 Class II | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1)…Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through… | Philips Medical Systems DMC GmbH | 10/01/2025Open, Classified |
| Z-2042-2023 Class II | DigitalDiagnost C90, Model No. 712034 and 712035There is a software login in issue that may prevent the user from logging in. | Philips North America Llc | 05/19/2023Open, Classified |
| Z-0239-2022 Class II | DigitalDiagnost C90The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic… | Philips Healthcare | 09/22/2021Open, Classified |
| Z-1992-2021 Class II | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the… | Liebel-Flarsheim Company LLC | 03/11/2021Terminated |
| Z-1176-2021 Class II | System INFX-8000FThe x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at… | Canon Medical System, USA, INC. | 02/05/2021Open, Classified |
| Z-1271-2021 Class II | Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B…System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit… | Canon Medical System, USA, INC. | 12/08/2020Open, Classified |
| Z-1765-2020 Class II | System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which…It was determined that in rare cases persons can receive low dose of unintended radiation. The system… | Siemens Medical Solutions USA, Inc | 04/06/2020Terminated |
| Z-2327-2020 Class II | Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This…Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table… | Canon Medical System, USA, INC. | 03/03/2020Open, Classified |
| Z-0842-2020 Class II | Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express… | Palodex Group Oy | 01/07/2020Terminated |
| Z-0841-2020 Class II | KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express… | Palodex Group Oy | 01/07/2020Terminated |
| Z-0840-2020 Class II | Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express… | Palodex Group Oy | 01/07/2020Terminated |
| Z-0839-2020 Class II | Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express… | Palodex Group Oy | 01/07/2020Terminated |
| Z-0360-2020 Class II | Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage:…Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short… | Canon Medical System, USA, INC. | 02/08/2019Terminated |
| Z-0697-2019 Class II | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe…A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high… | Swissray Medical AG | 11/14/2018Terminated |
| Z-0460-2019 Class II | RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage:…There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from… | Virtual Imaging, Inc. | 11/02/2018Terminated |
| Z-1958-2019 Class II | Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005…software malfunction; It was found when a user performs radiography using the wireless flat panel detector… | Canon Medical System, USA, INC. | 10/16/2018Terminated |
| Z-0239-2019 Class II | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models:…Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first… | Philips Medical Systems Gmbh, DMC | 09/19/2018Terminated |
| Z-0488-2019 Class II | Sedecal NOVA FA DR System. for diagnostic radiography.A safety problem with installation and maintenance could lead to the breakage of the two steel cables that… | Sedecal S.A. | 07/18/2018Open, Classified |
| Z-2868-2018 Class II | EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2867-2018 Class II | EasyDiagnost Eleva DRF (Stitching Patient Support) 706032The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2866-2018 Class II | DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2865-2018 Class II | DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2864-2018 Class II | DigitalDiagnost Upgrades (Stitching Patient Support) 712083The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2863-2018 Class II | DigitalDiagnost Single Detector (Stitching Patient Support) 712020The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2862-2018 Class II | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2861-2018 Class II | DigitalDiagnost Release 3 (Stitching Patient Support) 712025The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2860-2018 Class II | DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2859-2018 Class II | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2858-2018 Class II | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2857-2018 Class II | DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2856-2018 Class II | DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2855-2018 Class II | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2854-2018 Class II | DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2853-2018 Class II | DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2852-2018 Class II | DigitalDiagnost 4.1 (Stitching Patient Support) 712225The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2851-2018 Class II | DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2850-2018 Class II | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2849-2018 Class II | DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2848-2018 Class II | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2847-2018 Class II | CombiDiagnost R90 (Stitching Patient Support) 709030The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2846-2018 Class II | BuckyDiagnost Ceiling System (Stitching Patient Support) 704031The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2845-2018 Class II | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2844-2018 Class II | DigitalDiagnost Release 3 (Stitching Patient Support) 712025The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2843-2018 Class II | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2842-2018 Class II | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2841-2018 Class II | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or… | Philips Medical Systems Gmbh, DMC | 06/27/2018Terminated |
| Z-2281-2018 Class II | CS-7, Model No. A4C1Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire)… | Konica Minolta Medical Imaging USA, Inc. | 05/09/2018Terminated |
| Z-2964-2018 Class II | DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message… | Canon Medical System, USA, INC. | 04/18/2018Terminated |
| Z-1391-2018 Class II | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat…While transporting the portable machine with the retrofit equipment in a backwards motion, there is… | NeuroLogica Corporation | 01/12/2018Terminated |