FDR D-EVO flat Panel Detector System
FDA 510(k) K153464 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK153464
Submission
- Device name
- FDR D-EVO flat Panel Detector System
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Stamford, CT, US - Received
- December 1, 2015
- Decision date
- April 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQB
| 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 |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K171291 | FUJIFILM Bronchoscope Model EB-530PEOQ · Traditional | 01/19/2018SE |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MODG · Traditional | 01/11/2018SE |
| K173132 | ASPIRE CristalleMUE · Special | 10/27/2017SE |
| K171463 | ASPIRE Bellus IILLZ · Traditional | 09/29/2017SE |
| K152257 | Fujifilm Duodenoscope Model ED-530XTFDT · Traditional | 07/21/2017SE |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…MQB · Traditional | 06/30/2017SE |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFDS · Traditional | 06/15/2017SE |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife)KGE · Special | 05/09/2017SE |
| K170858 | FDR Aqro (Dr-Xd 1000)IZL · Traditional | 04/24/2017SE |
| K162287 | Synapse 3D Perfusion AnalysisLLZ · Traditional | 04/06/2017SE |
Questions and answers
When was FDR D-EVO flat Panel Detector System cleared by the FDA?
FDR D-EVO flat Panel Detector System (K153464) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 129 days after the submission was received.
What is the product code of K153464?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.