FDA Product Code
FDA Product Code MQB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1680
510(k) Clearances — 424 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | Varex Imaging Corporation | 2019-12-20 | Special | PDF ↗ |
| K193173 | CareView 1800Le | Careray Digital Medical System Co., Ltd. | 2019-12-13 | Special | PDF ↗ |
| K193031 | EXPD 4343P, EXPD 3643P | DRTECH Corporation | 2019-11-22 | Special | PDF ↗ |
| K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | DRTECH Corporation | 2019-11-22 | Special | PDF ↗ |
| K192932 | FDR D-EVO III flat panel detector system | Fujifilm Corporation | 2019-11-12 | Special | PDF ↗ |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | Canon, Inc. | 2019-11-07 | Special | PDF ↗ |
| K192440 | FDR SE Lite | Fujifilm Corporation | 2019-11-01 | Traditional | PDF ↗ |
| K192512 | Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang , Ltd. | 2019-10-16 | Special | PDF ↗ |
| K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | DRTECH Corporation | 2019-10-03 | Special | PDF ↗ |
| K191939 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2019-08-29 | Traditional | PDF ↗ |
| K191645 | SKR 4000 | Konica Minolta, Inc. | 2019-08-16 | Traditional | PDF ↗ |
| K190611 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2019-04-08 | Traditional | PDF ↗ |
| K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor Panel | Pixxgen Corporation | 2019-04-04 | Traditional | PDF ↗ |
| K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | 2019-03-13 | Special | PDF ↗ |
| K190300 | BIOK7600W Wireless Flat Panel Detector | Biokinemetrics, Inc. | 2019-03-13 | Traditional | PDF ↗ |
| K190311 | BIOK7600 Flat Panel Detector | Biokinemetrics, Inc. | 2019-03-13 | Traditional | PDF ↗ |
| K190146 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | 2019-03-08 | Special | PDF ↗ |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | Carestream Health, Inc. | 2019-02-08 | Traditional | PDF ↗ |
| K183474 | Carestream DRX-1 System with DRX Core Detectors | Carestream Health, Inc. | 2019-01-16 | Special | PDF ↗ |
| K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019-01-11 | Traditional | PDF ↗ |
| K183713 | Wireless Digital Flat Detector | Iray Technology Taicang , Ltd. | 2019-01-09 | Special | PDF ↗ |
| K183422 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2019-01-09 | Special | PDF ↗ |
| K182688 | SKR 3000 | Konica Minolta, Inc. | 2018-12-18 | Special | PDF ↗ |
| K183212 | Nexus DR Digital X-ray Imaging System with stitching | Varex Imaging Corporation | 2018-12-07 | Special | PDF ↗ |
| K183286 | 17HK701G-W | Lg Electronics.Inc | 2018-12-07 | Traditional | PDF ↗ |
| K182348 | 14HK701G-W | Lg Electronics.Inc | 2018-10-18 | Traditional | PDF ↗ |
| K182550 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2018-10-17 | Traditional | PDF ↗ |
| K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2018-10-17 | Traditional | PDF ↗ |
| K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | 2018-10-04 | Traditional | PDF ↗ |
| K181631 | GR40CW | Samsung Electronics Co., Ltd. | 2018-07-20 | Traditional | PDF ↗ |
| K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics, Inc. | 2018-07-13 | Special | PDF ↗ |
| K181526 | XRpad2 4343 HWC-M Flat Panel Detector | Varex Imaging Corporation | 2018-07-03 | Special | PDF ↗ |
| K180809 | Eclipse II | Carestream Health, Inc. | 2018-06-21 | Traditional | PDF ↗ |
| K180989 | PEDRA-17F Digital Flat Panel X-ray Detector | Radisen, Inc. | 2018-06-13 | Traditional | PDF ↗ |
| K180332 | 17HK700G-W | Lg Electronics | 2018-06-08 | Traditional | PDF ↗ |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | 2018-05-24 | Traditional | PDF ↗ |
| K181003 | VIVIX-S 1717V | Vieworks Co., Ltd. | 2018-05-15 | Traditional | PDF ↗ |
| K180667 | SmartGrid | Carestream Health, Inc. | 2018-04-13 | Special | PDF ↗ |
| K171270 | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS | Canon, Inc. | 2017-11-17 | Traditional | PDF ↗ |
| K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCI | Imaging Dynamics Company , Ltd. | 2017-11-09 | Special | PDF ↗ |
| K172124 | Televere Podiatry Digital Imaging System | Televere Systems | 2017-11-09 | Traditional | PDF ↗ |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Varex Imaging Corporation | 2017-10-24 | Special | PDF ↗ |
| K172784 | DX-D Imaging Package | Agfa Healthcare N.V. | 2017-10-13 | Traditional | PDF ↗ |
| K172435 | Galaxy R Digital Radiography Upgrade | Medien International Co, Ltd. | 2017-10-13 | Traditional | PDF ↗ |
| K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TG | Imaging Dynamics Company , Ltd. | 2017-10-12 | Special | PDF ↗ |
| K172793 | SKR 3000 | Konica Minolta, Inc. | 2017-10-12 | Special | PDF ↗ |
| K172682 | Edge Digital Flat Panel X-ray Detector | Osko, Inc. | 2017-10-06 | Traditional | PDF ↗ |
| K172681 | Edge Air Digital Flat Panel X-ray Detector | Osko, Inc. | 2017-10-06 | Traditional | PDF ↗ |
| K171175 | Aquarius 8600 1417WC | Imaging Dynamics Company , Ltd. | 2017-10-05 | Special | PDF ↗ |
| K172581 | CareView 1800Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2017-09-26 | Special | PDF ↗ |
| K171716 | SKR 3000 | Konica Minolta, Inc. | 2017-08-25 | Traditional | PDF ↗ |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Philips Medical Systems Dmc GmbH | 2017-07-07 | Traditional | PDF ↗ |
| K170480 | Models 3543A, 4343A, 2929A and A843B | Shanghai PZ Medical Technolgoy Co., Ltd. | 2017-07-07 | Traditional | PDF ↗ |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-30 | Traditional | PDF ↗ |
| K171485 | BSD4343R Digital Flat Panel X-ray Detector | Bontech, Inc. | 2017-06-21 | Special | PDF ↗ |
| K171417 | 1417WGC_127um and 1417WGC_140um | Rayence Co., Ltd. | 2017-06-12 | Special | PDF ↗ |
| K171418 | 1417WCC_127um and1417WCC_140um | Rayence Co., Ltd. | 2017-06-12 | Special | PDF ↗ |
| K171420 | 1717SCC_127um and 1717SCC_140um | Rayence Co., Ltd. | 2017-06-09 | Special | PDF ↗ |
| K171419 | 1717SGC_127um and 1717SGC_140um | Rayence Co., Ltd. | 2017-06-09 | Special | PDF ↗ |
| K171138 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | 2017-05-17 | Special | PDF ↗ |
| K171137 | EVS 2430W, EVS 2430GW | DRTECH Corporation | 2017-05-15 | Special | PDF ↗ |
| K171085 | GMR40 | Neurologica Corporation, A Subsidiary OF | 2017-05-11 | Traditional | PDF ↗ |
| K170975 | Televere Digital Imaging System | Televere Systems | 2017-05-01 | Traditional | PDF ↗ |
| K163157 | SmartGrid | Carestream Health | 2017-03-21 | Traditional | PDF ↗ |
| K170332 | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS | Canon, Inc. | 2017-03-01 | Traditional | PDF ↗ |
| K170202 | Aquarius 8600 | Imaging Dynamics Company , Ltd. | 2017-02-22 | Special | PDF ↗ |
| K170113 | pixium 4343RCE | Philips Medical Systems Dmc GmbH | 2017-02-09 | Special | PDF ↗ |
| K163703 | VIVIX-S 1417N | Vieworks Co., Ltd. | 2017-02-08 | Traditional | PDF ↗ |
| K162909 | CSX-30 Flat Panel Detector | Canon, Inc. Medical Equipment Group | 2017-01-27 | Traditional | PDF ↗ |
| K162555 | EVS 4343, EVS 4343G | DRTECH Corporation | 2016-12-21 | Special | PDF ↗ |
| K162344 | INNOLUX RIC | Innolux Corporation | 2016-12-20 | Traditional | PDF ↗ |
| K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai) , Ltd. | 2016-12-08 | Traditional | PDF ↗ |
| K162552 | EVS 3643, EVS 3643G | DRTECH Corporation | 2016-12-02 | Special | PDF ↗ |
| K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2016-12-01 | Special | PDF ↗ |
| K160143 | ClearVision ExamVue Flat Panel Detector | Jpi Healthcare, Inc. | 2016-10-28 | Traditional | PDF ↗ |
| K162487 | BSD3543 Digital Flat Panel X-ray Detector | Bontech, Inc. | 2016-10-14 | Special | PDF ↗ |
| K162519 | 1717WCC / 1717WGC | Rayence Co., Ltd. | 2016-10-06 | Special | PDF ↗ |
| K162518 | 1012WCC, 1012WGC | Rayence Co., Ltd. | 2016-10-06 | Special | PDF ↗ |
| K162504 | SKR 3000 | Konica Minolta, Inc. | 2016-10-03 | Traditional | PDF ↗ |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | Agfa Healthcare N.V. | 2016-09-22 | Traditional | PDF ↗ |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | Perkinelmer, Inc. | 2016-09-08 | Special | PDF ↗ |
| K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | Varian Medical Systems, X-Ray Products-Infimed | 2016-09-06 | Traditional | PDF ↗ |
| K162178 | CareView 1500P X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2016-09-01 | Special | PDF ↗ |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | Perkinelmer, Inc. | 2016-09-01 | Special | PDF ↗ |
| K153312 | SCATTER CORRECTION FOR CXDI SERIES | Canon, Inc. | 2016-06-28 | Traditional | PDF ↗ |
| K160204 | BSD4343 Digital Flat Panel X-ray Detector | Bontech, Inc. | 2016-06-09 | Traditional | PDF ↗ |
| K160810 | ViZion DR + Wireless | Viztek, LLC | 2016-05-20 | Traditional | PDF ↗ |
| K153464 | FDR D-EVO flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2016-04-08 | Traditional | PDF ↗ |
| K153710 | Tuxedo Digital Dental Sensor | Led Dental, Inc. | 2016-03-18 | Traditional | PDF ↗ |
| K152894 | VIVIX-S 1717N | Vieworks Co., Ltd. | 2016-02-26 | Traditional | PDF ↗ |
| K152855 | VIVIX-S 1012N | Vieworks Co., Ltd. | 2016-02-26 | Traditional | PDF ↗ |
| K153492 | CareView 1800L | Careray Digital Medical System Co., Ltd. | 2015-12-24 | Special | PDF ↗ |
| K153318 | Philips Eleva Workspot with SkyFlow | Philips Medical Systems Dmc GmbH | 2015-12-22 | Special | PDF ↗ |
| K153401 | GR40CW | Samsung Electronics Co., Ltd. | 2015-12-21 | Traditional | PDF ↗ |
| K152639 | DR 600 | Agfa Healthcare N.V. | 2015-12-11 | Traditional | PDF ↗ |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Carestream Health, Inc. | 2015-11-25 | Traditional | PDF ↗ |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015-11-10 | Special | PDF ↗ |
| K152151 | ATAL 9 | Atlaim Corporation | 2015-11-10 | Special | PDF ↗ |
| K152138 | FDR D-EVO GL Flat Panel Detector System | Fujifilm Medical System U.S.A., Inc. | 2015-11-05 | Traditional | PDF ↗ |
| K151942 | EVS 3643 | DRTECH Corporation | 2015-10-21 | Traditional | PDF ↗ |
Product code MQB · Class II · Radiology. Data: openFDA.