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424 FDA 510(k) clearances · Product code

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RecordFirmDate
Nexus DR Digital X-Ray Imaging System (with vSharp) (K193238)Varex Imaging Corporation2019-12-20
CareView 1800Le (K193173)Careray Digital Medical System Co., Ltd.2019-12-13
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP (K193017)DRTECH Corporation2019-11-22
EXPD 4343P, EXPD 3643P (K193031)DRTECH Corporation2019-11-22
FDR D-EVO III flat panel detector system (K192932)Fujifilm Corporation2019-11-12
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless (K192632)Canon, Inc.2019-11-07
FDR SE Lite (K192440)Fujifilm Corporation2019-11-01
Focus 35C Detector, Trimax 35C Detector (K192512)Iray Technology Taicang , Ltd.2019-10-16
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG (K192400)DRTECH Corporation2019-10-03
Yushan X-Ray Flat Panel Detector (K191939)Innocare Optoelectronics Corp.2019-08-29
SKR 4000 (K191645)Konica Minolta, Inc.2019-08-16
VIVIX-S 1751S (K190611)Vieworks Co., Ltd.2019-04-08
Pixx2430 Digital Diagnostic X-Ray Receptor Panel (K190691)Pixxgen Corporation2019-04-04
BIOK7600W Wireless Flat Panel Detector (K190300)Biokinemetrics, Inc.2019-03-13
Enhanced Feature Software Pack CXDI Series (K190368)Canon, Inc.2019-03-13
BIOK7600 Flat Panel Detector (K190311)Biokinemetrics, Inc.2019-03-13
Nexus DR Digital X-ray Imaging System (K190146)Varex Imaging Corporation2019-03-08
Carestream DRX-1 System with DRX Plus 2530 Detectors (K183245)Carestream Health, Inc.2019-02-08
Carestream DRX-1 System with DRX Core Detectors (K183474)Carestream Health, Inc.2019-01-16
DigitalDiagnost C90 (K182973)Philips Medical Systems Dmc GmbH2019-01-11
Wireless Digital Flat Panel Detector (K183422)Iray Technology Taicang , Ltd.2019-01-09
Wireless Digital Flat Detector (K183713)Iray Technology Taicang , Ltd.2019-01-09
SKR 3000 (K182688)Konica Minolta, Inc.2018-12-18
17HK701G-W (K183286)Lg Electronics.Inc2018-12-07
Nexus DR Digital X-ray Imaging System with stitching (K183212)Varex Imaging Corporation2018-12-07
14HK701G-W (K182348)Lg Electronics.Inc2018-10-18
Wireless Digital Flat Panel Detector (K182550)Iray Technology Taicang , Ltd.2018-10-17
Wireless Digital Flat Panel Detector (K182551)Iray Technology Taicang , Ltd.2018-10-17
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels (K182533)Pixxgen Corporation2018-10-04
GR40CW (K181631)Samsung Electronics Co., Ltd.2018-07-20
Aquarius 8600 Digital Radiography Sensor (K181565)Biokinemetrics, Inc.2018-07-13
XRpad2 4343 HWC-M Flat Panel Detector (K181526)Varex Imaging Corporation2018-07-03
Eclipse II (K180809)Carestream Health, Inc.2018-06-21
PEDRA-17F Digital Flat Panel X-ray Detector (K180989)Radisen, Inc.2018-06-13
17HK700G-W (K180332)Lg Electronics2018-06-08
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels (K180976)Pixxgen Corporation2018-05-24
VIVIX-S 1717V (K181003)Vieworks Co., Ltd.2018-05-15
SmartGrid (K180667)Carestream Health, Inc.2018-04-13
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS (K171270)Canon, Inc.2017-11-17
Televere Podiatry Digital Imaging System (K172124)Televere Systems2017-11-09
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI (K173273)Imaging Dynamics Company , Ltd.2017-11-09
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) (K172951)Varex Imaging Corporation2017-10-24
DX-D Imaging Package (K172784)Agfa Healthcare N.V.2017-10-13
Galaxy R Digital Radiography Upgrade (K172435)Medien International Co, Ltd.2017-10-13
Aquarius 8600 1417TG and Aquarius 8600 1717TG (K171169)Imaging Dynamics Company , Ltd.2017-10-12
SKR 3000 (K172793)Konica Minolta, Inc.2017-10-12
Edge Air Digital Flat Panel X-ray Detector (K172681)Osko, Inc.2017-10-06
Edge Digital Flat Panel X-ray Detector (K172682)Osko, Inc.2017-10-06
Aquarius 8600 1417WC (K171175)Imaging Dynamics Company , Ltd.2017-10-05
CareView 1800Cw X-ray Flat Panel Detectors (K172581)Careray Digital Medical System Co., Ltd.2017-09-26
SKR 3000 (K171716)Konica Minolta, Inc.2017-08-25
Models 3543A, 4343A, 2929A and A843B (K170480)Shanghai PZ Medical Technolgoy Co., Ltd.2017-07-07
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems (K171461)Philips Medical Systems Dmc GmbH2017-07-07
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (K163624)Fujifilm Medical Systems U.S.A, Inc.2017-06-30
BSD4343R Digital Flat Panel X-ray Detector (K171485)Bontech, Inc.2017-06-21
1417WCC_127um and1417WCC_140um (K171418)Rayence Co., Ltd.2017-06-12
1417WGC_127um and 1417WGC_140um (K171417)Rayence Co., Ltd.2017-06-12
1717SGC_127um and 1717SGC_140um (K171419)Rayence Co., Ltd.2017-06-09
1717SCC_127um and 1717SCC_140um (K171420)Rayence Co., Ltd.2017-06-09
Nexus DR Digital X-ray Imaging System (K171138)Varex Imaging Corporation2017-05-17
EVS 2430W, EVS 2430GW (K171137)DRTECH Corporation2017-05-15
GMR40 (K171085)Neurologica Corporation, A Subsidiary OF2017-05-11
Televere Digital Imaging System (K170975)Televere Systems2017-05-01
SmartGrid (K163157)Carestream Health2017-03-21
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS (K170332)Canon, Inc.2017-03-01
Aquarius 8600 (K170202)Imaging Dynamics Company , Ltd.2017-02-22
pixium 4343RCE (K170113)Philips Medical Systems Dmc GmbH2017-02-09
VIVIX-S 1417N (K163703)Vieworks Co., Ltd.2017-02-08
CSX-30 Flat Panel Detector (K162909)Canon, Inc. – Medical Equipment Group2017-01-27
EVS 4343, EVS 4343G (K162555)DRTECH Corporation2016-12-21
INNOLUX RIC (K162344)Innolux Corporation2016-12-20
Wireless Digital Flat Panel Detector (K161730)Iray Technology (Shanghai) , Ltd.2016-12-08
EVS 3643, EVS 3643G (K162552)DRTECH Corporation2016-12-02
CareView 750Cw/750C X-ray Flat Panel Detectors (K163019)Careray Digital Medical System Co., Ltd.2016-12-01
ClearVision ExamVue Flat Panel Detector (K160143)Jpi Healthcare, Inc.2016-10-28
BSD3543 Digital Flat Panel X-ray Detector (K162487)Bontech, Inc.2016-10-14
1717WCC / 1717WGC (K162519)Rayence Co., Ltd.2016-10-06
1012WCC, 1012WGC (K162518)Rayence Co., Ltd.2016-10-06
SKR 3000 (K162504)Konica Minolta, Inc.2016-10-03
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) (K161368)Agfa Healthcare N.V.2016-09-22
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (K161966)Perkinelmer, Inc.2016-09-08
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) (K161459)Varian Medical Systems, X-Ray Products-Infimed2016-09-06
CareView 1500P X-ray Flat Panel Detectors (K162178)Careray Digital Medical System Co., Ltd.2016-09-01
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector (K161942)Perkinelmer, Inc.2016-09-01
SCATTER CORRECTION FOR CXDI SERIES (K153312)Canon, Inc.2016-06-28
BSD4343 Digital Flat Panel X-ray Detector (K160204)Bontech, Inc.2016-06-09
ViZion DR + Wireless (K160810)Viztek, LLC2016-05-20
FDR D-EVO flat Panel Detector System (K153464)Fujifilm Medical Systems U.S.A, Inc.2016-04-08
Tuxedo Digital Dental Sensor (K153710)Led Dental, Inc.2016-03-18
VIVIX-S 1717N (K152894)Vieworks Co., Ltd.2016-02-26
VIVIX-S 1012N (K152855)Vieworks Co., Ltd.2016-02-26
CareView 1800L (K153492)Careray Digital Medical System Co., Ltd.2015-12-24
Philips Eleva Workspot with SkyFlow (K153318)Philips Medical Systems Dmc GmbH2015-12-22
GR40CW (K153401)Samsung Electronics Co., Ltd.2015-12-21
DR 600 (K152639)Agfa Healthcare N.V.2015-12-11
Carestream DRX-1 System with DRX Plus 4343 Detectors (K153142)Carestream Health, Inc.2015-11-25
ATAL 9 (K152151)Atlaim Corporation2015-11-10
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors (K153058)Careray Digital Medical System Co., Ltd.2015-11-10
FDR D-EVO GL Flat Panel Detector System (K152138)Fujifilm Medical System U.S.A., Inc.2015-11-05
EVS 3643 (K151942)DRTECH Corporation2015-10-21
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