System, X-Ray, Extraoral Source, Digital
FDA product code MUH · Class II (moderate risk) · 21 CFR 872.1800 · Dental
206510(k) clearances
0PMA approvals
9recalls
Manufacturers
- VATECH Co., Ltd. 8
- Genoray Co., Ltd. 7
- Sirona Dental Systems GmbH 7
- Trophy 6
- Schick Technologies, Inc. 5
- Instrumentarium Dental, Palodex Group OY 5
- Planmeca Oy 5
- Ray Co., Ltd. 5
- Owandy 5
- Soredex Palodex Group OY 5
- Dexcowin Co., Ltd. 4
- Rayence Co., Ltd. 4
- Midmark Corp. 3
- Afp Imaging Corp. 3
- Air Techniques, Inc. 3
- Dentimax, Inc. 3
- Takara Belmont USA, Inc. 3
- Sopro - Acteon Group 3
- Suni Medical Imaging, Inc. 3
- Takara Belmont Corporation 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5)MUH · Traditional | Sota Cloud Corp. | 03/03/2026SE |
| K252570 | EzSensor HD, EzSensor UHDMUH · Special | Qpix Solutions, Inc. | 11/10/2025SE |
| K250687 | Cocoon Solo (DX-7020s)MUH · Traditional | Dexcowin Global, Inc. | 10/24/2025SE |
| K251206 | Digital X-Ray DentiMax Pro Imaging SystemMUH · Traditional | Dentimax, Inc. | 09/24/2025SE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional | VATECH Co., Ltd. | 10/25/2024SE |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF)MUH · Special | Qpix Solutions, Inc. | 10/11/2024SE |
| K241649 | DUO1 and DUO2MUH · Traditional | Zinnovi, Inc. | 07/05/2024SE |
| K232325 | RAYSCAN a-ExpertMUH · Traditional | Ray Co., Ltd. | 04/18/2024SE |
| K231660 | Digital image scanner of dentalMUH · Traditional | Jiangsu Dynamic Medical Technology Co., Ltd. | 12/20/2023SE |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…MUH · Traditional | Dental Imaging Technologies Corporation | 11/21/2023SE |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B)MUH · Abbreviated | Tuxedo Imaging, LLC | 10/20/2023SE |
| K230998 | Digital Wireless Intraoral X-Ray SensorMUH · Special | Iray Imaging Technology (Haining) Limited | 10/20/2023SE |
| K230916 | WeSensorMUH · Traditional | Picopack, Inc. | 10/10/2023SE |
| K232255 | EZSensor XHDMUH · Traditional | Qpix Solutions, Inc. | 09/27/2023SE |
| K232158 | GenX-CRMUH · Traditional | Genoray Co., Ltd. | 09/13/2023SE |
| K231202 | QuickRayPROMUH · Traditional | Denterprise International, Inc. | 06/22/2023SE |
| K230811 | Digital Intraoral X-Ray SensorMUH · Special | Iray Imaging Technology (Haining) Limited | 04/21/2023SE |
| K230732 | Eagle S/Saevo Slim/D700 SlimMUH · Traditional | Alliage S/A Industrias Medica Odontológico. | 04/11/2023SE |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0MUH · Special | Durr Dental SE | 02/06/2023SE |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20MUH · Traditional | Realcloud Imaging Inc. Dba Realcloud Imaging | 08/31/2022SE |
| K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)MUH · Traditional | Shanghai Handy Medical Equipment Co., Ltd. | 06/22/2022SE |
| K220423 | PAPAYA & PAPAYA PlusMUH · Traditional | Genoray Co., Ltd. | 05/19/2022SE |
| K220556 | OpenSensorX SeriesMUH · Special | Dentimax, Inc. | 04/13/2022SE |
| K220422 | Dental sensors NanoPix1, NanoPix2MUH · Special | Iray Technology Taicang , Ltd. | 03/11/2022SE |
| K214091 | Dental Image Plate Scanner, Model DFC-4T-SMARTMUH · Traditional | Hefei Dentafilm Medical Equipment Co., Ltd. | 03/02/2022SE |
| K220277 | Digital Intraoral X-ray SensorMUH · Traditional | Shenzhen Xpectvision Technology Co., Ltd. | 02/17/2022SE |
| K213637 | JAZZ Solo sensorMUH · Special | Jazz Imaging, LLC Dba Jazz Imaging | 12/10/2021SE |
| K212279 | Digital Intraoral X-ray Imaging SystemMUH · Traditional | Iray Technology Taicang , Ltd. | 10/07/2021SE |
| K212080 | Imaging Plate Scanner, i-ScanMUH · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 09/27/2021SE |
| K202369 | RXS 1000MUH · Traditional | Rolence Enterprise, Inc. | 09/15/2021SE |
| K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2MUH · Traditional | Fona S.R.L | 08/30/2021SE |
| K211317 | CruxviewMUH · Traditional | Cruxell Corp. | 07/29/2021SE |
| K211688 | DC-Air and Athlos-1 and Athlos-AirMUH · Traditional | Athlos OY | 07/22/2021SE |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging SystemMUH · Traditional | Iray Technology Taicang , Ltd. | 04/23/2021SE |
| K203116 | SensorXMUH · Traditional | Durr Dental SE | 03/19/2021SE |
| K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)MUH · Abbreviated | De Götzen S.R.L. | 02/05/2021SE |
| K202664 | Clio Prime and Clio PedoMUH · Traditional | Sota Precision Optics, Inc. Dba Sota Imaging | 11/06/2020SE |
| K202633 | ScanX EdgeMUH · Special | Dürr Dental SE | 10/07/2020SE |
| K200625 | I-View Gold and Imagen Gold Dental SensorsMUH · Traditional | Trident S.R.L | 04/15/2020SE |
| K200284 | R-Sensor, R-SensorMUH · Traditional | Remedi Co., Ltd. | 02/28/2020SE |
| K191719 | X-MIND TriumMUH · Traditional | De Gotzen S.R.L. | 02/20/2020SE |
| K192766 | Digital Intraoral Imaging Plate SystemMUH · Traditional | Fsusen Technology Co., Ltd. | 12/05/2019SE |
| K191623 | ScanX Touch/ScanX Duo TouchMUH · Traditional | Air Techniques, Inc. | 08/21/2019SE |
| K190234 | ODI HD Dental SensorMUH · Traditional | Cnd Global Technologies, Inc. | 03/01/2019SE |
| K183637 | Cruxcan (CRX-1000)MUH · Traditional | Cruxell Corp. | 02/12/2019SE |
| K182198 | Panoura X-ERA PF/NF/MFMUH · Traditional | The Yoshida Dental Mfg. Co., Ltd. | 01/31/2019SE |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S)MUH · Traditional | Hdx Will Corp. | 11/21/2018SE |
| K181636 | AuroraMUH · Traditional | Sodium Systems, LLC | 07/20/2018SE |
| K181358 | Televere Digital Dental Imaging SystemMUH · Traditional | Televere Systems, Inc. | 06/20/2018SE |
| K173646 | FS ErgoMUH · Traditional | Palodex Group OY | 12/19/2017SE |
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)MUH · Traditional | Kavo Dental Technologies, LLC | 12/18/2017SE |
| K173046 | Cocoon Portable Handheld X-Ray SystemMUH · Special | Dexcowin Co., Ltd. | 10/26/2017SE |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark…MUH · Abbreviated | Villa Sistemi Medicali S.P.A. | 07/06/2017SE |
| K170733 | ScanX Intraoral ViewMUH · Traditional | Duerr Dental AG | 05/01/2017SE |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightMUH · Traditional | VATECH Co., Ltd. | 04/04/2017SE |
| K163175 | Bel-Cypher ProMUH · Traditional | Takara Belmont Corporation | 03/20/2017SE |
| K163224 | JAZZ SOLO SensorMUH · Traditional | Jazz Imaging, LLC | 03/09/2017SE |
| K163282 | Apex Dental SensorsMUH · Traditional | Masterlink, LLC | 02/28/2017SE |
| K162619 | I View and Imagen SensorMUH · Traditional | Trident S.R.L | 11/04/2016SE |
| K162585 | SuniIQ Digital Radiography SystemMUH · Traditional | Suni Medical Imaging, Inc. | 11/04/2016SE |
| K161131 | FONA Pan/CephMUH · Traditional | Fona S.R.L | 11/03/2016SE |
| K160788 | RIOScan (RPS500)MUH · Traditional | Ray Co., Ltd. | 04/15/2016SE |
| K160386 | ReadeR, VieweR, QuickScan PSPMUH · Traditional | Trident S.R.L | 03/10/2016SE |
| K153144 | Tio-H Digital Radiography SensorMUH · Traditional | Denttio, Inc. | 02/10/2016SE |
| K152162 | Myray- HYPERION X5MUH · Traditional | Cefla S.C. | 12/24/2015SE |
| K151926 | QuickRay HD Intraoral SensorMUH · Traditional | Denterprise International, Inc. | 12/14/2015SE |
| K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-SMUH · Special | Rayence Co., Ltd. | 11/10/2015SE |
| K150823 | EDLENi Intra-Oral SensorMUH · Abbreviated | Edlen Imaging, LLC | 08/26/2015SE |
| K151087 | CS 8100SC, CS8100SC AccessMUH · Traditional | Trophy | 08/21/2015SE |
| K142995 | SopixMUH · Traditional | Sopro - Acteon Group | 08/17/2015SE |
| K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for…MUH · Traditional | Sopro - Acteon Group | 07/31/2015SE |
| K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iMUH · Special | Rayence Co., Ltd. | 07/19/2015SE |
| K150797 | Digital Dental Intra Oral Sensor, EzSensor SmartMUH · Special | Rayence Co., Ltd. | 05/01/2015SE |
| K142058 | Rayscan A-ExpertMUH · Traditional | Ray Co., Ltd. | 04/22/2015SE |
| K143703 | NICAL SMART MICRO CR system for intraoral dental imagesMUH · Traditional | Nical Spa | 03/18/2015SE |
| K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor BioMUH · Special | Rayence Co., Ltd. | 03/10/2015SE |
| K141700 | Papaya Plus, Digital Extraoral Source X-Ray SystemMUH · Traditional | Genoray Co., Ltd. | 10/31/2014SE |
| K140013 | Sopix Inside, SOPIX2 InsideMUH · Traditional | Sopro - Acteon Group | 09/05/2014SE |
| K141130 | EncompassMUH · Traditional | Panoramic Corp. | 07/30/2014SE |
| K133206 | Z-Ray Intra-Oral Digital Radiography SystemMUH · Traditional | Zuma Dental, LLC | 05/13/2014SE |
| K134055 | ADX4000WMUH · Special | Dexcowin Co., Ltd. | 05/09/2014SE |
| K133271 | Opteo, Videograph HDMUH · Special | Owandy | 04/28/2014SE |
| K133007 | DX3000-LMUH · Special | Dexcowin Co., Ltd. | 04/24/2014SE |
| K133231 | Digora OptimeMUH · Special | Instrumentarium Dental, Palodex Group OY | 03/20/2014SE |
| K130419 | Papaya Plus, Digital Extraoral Source X-Ray SystemMUH · Traditional | Genoray Co., Ltd. | 11/06/2013SE |
| K131693 | Rayscan A-ExpertMUH · Special | Ray Co., Ltd. | 11/01/2013SE |
| K131442 | Firecr Dentalimaging SystemMUH · Traditional | 3Disc Americas | 09/06/2013SE |
| K130088 | Port View, Digital X-Ray Sensor SystemMUH · Traditional | Genoray Co., Ltd. | 07/18/2013SE |
| K130585 | PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray…MUH · Traditional | VATECH Co., Ltd. | 07/15/2013SE |
| K122918 | Rayscan A-ExpertMUH · Traditional | Ray Co., Ltd. | 03/15/2013SE |
| K122806 | Image Works PanouraMUH · Traditional | Mic International | 03/08/2013SE |
| K121800 | Point 500 HD POINT500C HDMUH · Traditional | Pointnix Co., Ltd. | 01/24/2013SE |
| K122643 | Vantage Model V5000, V5100, V5000C, V5100CMUH · Traditional | Midmark Corp. | 01/07/2013SE |
| K123419 | Eva Select Digital Dental Imaging SystemMUH · Special | Afp Imaging Corp. | 12/27/2012SE |
| K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemMUH · Special | VATECH Co., Ltd. | 09/04/2012SE |
| K120263 | Volux 21C, Digital Extraoral Source X-Ray SystemMUH · Traditional | Genoray Co., Ltd. | 07/10/2012SE |
| K120975 | CS 8100 CS 8100 AccessMUH · Traditional | Trophy | 06/22/2012SE |
| K120106 | Apixia Digirex Digital Dental Rediography SystemMUH · Traditional | Apixia, Inc. | 05/07/2012SE |
| K113672 | PCH-2500 Digital Extraoral Source X-Ray SystemMUH · Traditional | VATECH Co., Ltd. | 03/27/2012SE |
| K120318 | Vivi Ergon-X HFMUH · Traditional | Vivi S.R.L. | 03/06/2012SE |
| K113497 | HyperionMUH · Traditional | Cefla S.C. Cefla Dental Group | 01/17/2012SE |
| K111103 | Digital X-Ray Imaging SystemMUH · Traditional | Rf Co., Ltd. | 01/05/2012SE |
| K102456 | Intraoral Belsensor GoldMUH · Traditional | Takara Belmont USA, Inc. | 12/15/2011SE |
| K112380 | ClearvisionMUH · Traditional | Midmark Corp. | 11/22/2011SE |
| K111649 | CS 7600MUH · Traditional | Carestream Health, Inc. | 09/23/2011SE |
| K103290 | Edlen Imaging - Gemini DusbMUH · Abbreviated | Edlen Imaging, LLC | 09/19/2011SE |
| K111152 | Rotograph Evo 3DMUH · Abbreviated | Villa Sistemi Medicali S.P.A. | 07/22/2011SE |
| K111231 | Panoura 18SMUH · Traditional | The Yoshida Dental Mfg. Co., Ltd. | 07/13/2011SE |
| K110768 | Computed Dental RadiographyMUH · Special | Schick Technologies, Inc. | 04/20/2011SE |
| K110371 | Encompass HF100- Eagle Panoramic/Cephalometric X-RayMUH · Traditional | Panoramic Corp. | 03/17/2011SE |
| K103689 | Planmeca Promax 3D MidMUH · Traditional | Planmeca Oy | 03/17/2011SE |
| K110160 | Bel-Cypher NMUH · Special | Takara Belmont Corporation | 02/17/2011SE |
| K102124 | Dental Computed Tomography X-Ray SystemMUH · Traditional | VATECH Co., Ltd. | 10/22/2010SE |
| K100960 | WDS X-Pod and Zen-X Digital X-Ray SensorsMUH · Traditional | Cefla Dental Group | 10/21/2010SE |
| K093683 | Orthopantomograph OP300MUH · Traditional | Instrumentarium Dental, Palodex Group OY | 10/06/2010SE |
| K101661 | Myray HyperionMUH · Traditional | Cefla Dental Group | 09/16/2010SE |
| K092329 | Sopix 2MUH · Traditional | Sopro | 07/20/2010SE |
| K093590 | Planmeca Promax 3D MaxMUH · Traditional | Planmeca Oy | 05/12/2010SE |
| K093478 | Kodak RVG 6500 System and Kodak RVG 6500 Ips SystemMUH · Traditional | Trophy | 04/26/2010SE |
| K092171 | Volux, Digital Extraoral Source X-Ray SystemMUH · Traditional | Genoray Co., Ltd. | 04/26/2010SE |
| K100317 | Digital X-Ray Imaging System (Pax-Primo) Model Pax-PrimoMUH · Traditional | VATECH Co., Ltd. | 03/24/2010SE |
| K090526 | Medical Image Processing Unit, Model EzsensorMUH · Traditional | E-Woo Technology | 12/02/2009SE |
| K092591 | Orthopantomograph OP30MUH · Traditional | Instrumentarium Dental, Palodex Group OY | 11/20/2009SE |
| K092547 | Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control BoxMUH · Traditional | Dentimax | 10/30/2009SE |
| K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540MUH · Traditional | Toshiba America Electronic Components, Inc. | 08/27/2009SE |
| K091866 | Progeny Vantage Panoramic X-Ray SystemMUH · Traditional | Midmark | 07/20/2009SE |
| K083057 | I-Max TouchMUH · Traditional | Owandy | 06/02/2009SE |
| K090458 | Dexis SensorMUH · Traditional | Dexis, LLC | 05/28/2009SE |
| K090020 | Bel-Cypher, Model Y977MUH · Traditional | Takara-Belmont Co., Ltd. | 03/13/2009SE |
| K083532 | ADX4000-L, DX3000-LMUH · Traditional | Dexcowin Co., Ltd. | 03/10/2009SE |
| K082972 | Kodak 9500MUH · Traditional | Trophy | 12/05/2008SE |
| K081088 | Myray SkyviewMUH · Abbreviated | Cefla S.C. | 11/06/2008SE |
| K081925 | SnapshotMUH · Traditional | Instrumentarium Dental, Palodex Group OY | 09/02/2008SE |
| K081903 | Xios Plus Wall-ModuleMUH · Traditional | Sirona Dental Systems GmbH | 08/26/2008SE |
| K080889 | Kodak 9000C Extraoral Imaging SystemMUH · Special | Trophy | 04/29/2008SE |
| K073696 | VeraviewepocsMUH · Traditional | J. Morita USA, Inc. | 04/08/2008SE |
| K073365 | Dental Digital X-Ray Imaging SystemMUH · Traditional | VATECH Co., Ltd. | 04/08/2008SE |
| K073435 | Kodak 9000, Kodak 9000 3DMUH · Traditional | Trophy | 02/11/2008SE |
| K073350 | Scanora 3DMUH · Traditional | Soredex Palodex Group OY | 12/19/2007SE |
| K072134 | Schick Computed Oral Radiology SystemMUH · Special | Schick Technologies, Inc. | 11/02/2007SE |
| K072244 | Planmeca ProoneMUH · Traditional | Planmeca Oy | 09/21/2007SE |
| K072357 | Newtom VG Computed Tomography X-Ray SystemMUH · Special | Afp Imaging Corp. | 09/18/2007SE |
| K070811 | Cordless Portable Dental X-Ray System, Model ADX4000MUH · Traditional | Dexco | 07/05/2007SE |
| K063837 | Sigma MMUH · Traditional | Instrumentarium Dental, Palodex Group OY | 07/02/2007SE |
| K070664 | Progeny Imaging Software, Model# 500-405 (6,7,8).MUH · Traditional | Progeny, Inc. | 04/26/2007SE |
| K070535 | Retropan Ccd-Twain-UsbMUH · Traditional | Video Dental Concepts, Inc. | 04/24/2007SE |
| K070505 | Krystal-X WifiMUH · Traditional | Owandy | 04/05/2007SE |
| K070304 | Digora Pct/DigipodMUH · Traditional | Soredex Palodex Group OY | 03/27/2007SE |
| K070219 | Suniray II Digital Radiography SystemMUH · Traditional | Suni Medical Imaging, Inc. | 02/07/2007SE |
| K063459 | Cranex NovusMUH · Traditional | Soredex Palodex Group OY | 12/26/2006SE |
| K062403 | Imax Ceph Digital X-Ray SensorMUH · Traditional | Owandy | 11/14/2006SE |
| K062529 | Belmax CM Model X168MUH · Traditional | Takara Belmont USA, Inc. | 10/05/2006SE |
| K061284 | I-Cat ScannerMUH · Traditional | Imaging Sciences Intl., Inc. | 07/03/2006SE |
| K053172 | Universal-X (USA) or /Krystal-X (Europe)MUH · Traditional | Owandy Sas | 06/09/2006SE |
| K061114 | WDS, Size 2 and Size 2MUH · Abbreviated | Cefla S.C.R.L. | 06/06/2006SE |
| K060892 | GalileosMUH · Traditional | Sirona Dental Systems GmbH | 04/14/2006SE |
| K060328 | Planmeca Promax 3DMUH · Traditional | Planmeca Oy | 03/15/2006SE |
| K060178 | Vix Win ProMUH · Traditional | Gendex Dental Systems | 03/10/2006SE |
| K053558 | Ceph, Model 4900MUH · Traditional | Schick Technologies, Inc. | 02/17/2006SE |
| K060179 | Bio-Ray SDX Digital X-Ray SystemMUH · Traditional | Sigma Biomedics, Inc. | 02/08/2006SE |
| K060079 | Kodak Model CR-7400 Digital Radiography SystemMUH · Special | Eastman Kodak Company | 02/08/2006SE |
| K060149 | Sunipan Imaging System & AccessoriesMUH · Traditional | Suni Medical Imaging, Inc. | 02/03/2006SE |
| K053221 | Cdmx-HMUH · Traditional | Camsight Co., Inc. | 01/12/2006SE |
| K053220 | Veraview Ic 5, Model XDP1MUH · Traditional | J. Morita USA, Inc. | 01/06/2006SE |
| K051664 | SCAN300FP / Retropan (VDC)MUH · Traditional | Oy Ajat, Ltd. | 07/20/2005SE |
| K050693 | AccentMUH · Traditional | Air Techniques, Inc. | 05/26/2005SE |
| K041834 | Adr Plus Ssxi Imaging Device for X-Ray Systems Such AS X-Caliber, X-Caliber CM, Ana-Bel…MUH · Traditional | Takara Belmont USA, Inc. | 12/03/2004SE |
| K042736 | CDX Digital X-Ray Imaging SystemMUH · Traditional | Cnc Imaging, Inc. | 10/13/2004SE |
| K042372 | HDS Intra-Oral Imaging SystemMUH · Traditional | Vatech Value Added Technology Co., Ltd. | 10/04/2004SE |
| K041120 | Ev Apan Digital, Model K1VSM2000MUH · Traditional | Afp Imaging Corp. | 08/30/2004SE |
| K041831 | Progeny Mpse Intraoral Dental X-Ray SensorMUH · Traditional | Progeny, Inc. | 08/09/2004SE |
| K041580 | ImagerayiMUH · Traditional | Henry Schein, Inc. | 06/29/2004SE |
| K041050 | Digora Optime (or Digora Ontime)MUH · Traditional | Soredex Palodex Group OY | 06/15/2004SE |
| K024186 | X-ViewMUH · Traditional | Sometech Corporation | 04/01/2004SE |
| K033147 | Cleartooth Digital X-Ray SystemMUH · Traditional | Cleartooth Electronics, Inc. | 12/30/2003SE |
| K033248 | Hitachi CB Mercuray Dental Cone-Beam X-Ray SystemMUH · Traditional | Hitachi Medical Systems America, Inc. | 10/20/2003SE |
| K031801 | Pantos, Models: Pantos 16, and Pantos DGMUH · Traditional | Blue X Imaging Srl | 09/11/2003SE |
| K031291 | CDR Panx, Model 4792MUH · Traditional | Schick Technologies, Inc. | 05/05/2003SE |
| K023346 | TrophypanMUH · Traditional | Trophy Radiologie | 01/03/2003SE |
| K023292 | Apex Hri Digital Radiography SystemMUH · Traditional | Krugman Technologies, Inc. | 12/13/2002SE |
| K022953 | Modification to Computed Oral Radiology SystemMUH · Special | Schick Technologies, Inc. | 10/02/2002SE |
| K021718 | Intraoral Imaging System, Model Suni-RayMUH · Traditional | Suni Imaging Microsystems, Inc. | 08/15/2002SE |
| K021542 | Adc DentalMUH · Traditional | Agfa Corp. | 08/06/2002SE |
| K020588 | X-Image Digital X-Ray SystemMUH · Traditional | Escape Technology, Inc. | 06/13/2002SE |
| K013893 | ScanxMUH · Traditional | Air Techniques, Inc. | 02/01/2002SE |
| K012514 | Digipan / DpiMUH · Traditional | Trophy Radiologie | 12/21/2001SE |
| K013271 | DXS Digital X-Ray SystemMUH · Traditional | Douglas C. Yoon, Dds | 12/13/2001SE |
| K013659 | Modification to Sidexis Digital Radiography Imaging SystemMUH · Special | Sirona Dental Systems GmbH | 12/06/2001SE |
| K013650 | Orthophos Ds/Dc Ceph, Orthophos 5/PLUS/CDMUH · Special | Sirona Dental Systems GmbH | 12/06/2001SE |
| K012170 | Digora PCTMUH · Traditional | Soredex Palodex Group OY | 08/10/2001SE |
| K010915 | CDMXMUH · Traditional | Camsight Co., Inc. | 05/21/2001SE |
| K002425 | Mediadent Hdx/Mmd HDX SP Xray SensorMUH · Traditional | Multi Media Dental Systems, Inc. | 12/21/2000SE |
| K001928 | SigmaMUH · Traditional | Instrumentarium Imaging, Inc. | 08/02/2000SE |
| K001439 | Orthoceph OC100 DMUH · Traditional | Instrumentarium Corp. | 06/22/2000SE |
| K992392 | RTLXMUH · Traditional | Infimed, Inc. | 03/31/2000SE |
| K000454 | Dimex 2MUH · Traditional | Planmeca Oy | 03/31/2000SE |
| K993958 | IDX-60 Intraoral X-RayMUH · Traditional | X-Cel X-Ray Corp. | 02/14/2000SE |
| K992385 | Orthopantomograph OP100DMUH · Traditional | Instrumentarium Corp. | 09/28/1999SE |
| K992644 | Sidexis Digital Radiography Imaging SystemMUH · Special | Sirona Dental Systems GmbH | 08/23/1999SE |
| K990087 | DMD Digital X-Ray SystemMUH · Traditional | Dental/Medical Diagnostic Systems, Inc. | 05/13/1999SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1387-2019 Class II | DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a…The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in… | KaVo Dental Technologies LLC | 04/29/2019Terminated |
| Z-0128-2016 Class II | Villa Sistemi Rotograph EVO 3D X-rayIt has been discovered that due to lack of information accompanying documents the product fails to comply… | Villa Radiology Systems LLC | 08/05/2015Terminated |
| Z-1378-2015 Class II | CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented…Units device head descended unexpectedly | Carestream Health, Inc. | 01/08/2015Terminated |
| Z-1377-2015 Class II | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete…Units device head descended unexpectedly | Carestream Health, Inc. | 01/08/2015Terminated |
| Z-0651-2016 Class II | Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological…Failure of the primary collimator may result in unintentional movement of the device. The unintentional… | Midmark Corp dba Progeny Inc | 09/04/2014Terminated |
| Z-0651-2014 Class II | The Vantage Digital Panoramic System delivers high-value features standard on every…An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in… | Midmark Corp dba Progeny Inc | 09/20/2013Terminated |
| Z-1548-2009 | Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental…There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction… | Gendex Dental Systems | 03/06/2009Terminated |
| Z-1265-2009 | Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is…faulty calibration | Imaging Sciences International, LLC | 01/08/2009Terminated |
| Z-1646-2008 | i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a…Incorrect scatter information in the manual. | Imaging Sciences Intl Inc | 03/19/2008Terminated |