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424 FDA 510(k) clearances · Product code

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RecordFirmDate
GR40CW (K152094)Samsung Electronics Co., Ltd.2015-10-16
ViZion DR + Wireless (K152279)Viztek, LLC2015-09-10
CAREVIEW 1800R (K141488)Careray Digital Medical System Co., Ltd.2015-09-08
CareView 1500Cw X-ray Flat Panel Detectors (K150929)Careray Digital Medical System Co., Ltd.2015-08-04
Aura DR 43C-AG flat panel detector (K151014)Abyzr Co., Ltd.2015-07-13
AeroDR SYSTEM 2 (K151465)Konica Minolta, Inc.2015-06-29
Carestream DRX-1 System (K150766)Carestream Health, Inc.2015-06-24
Kubtec DIGIVIEW 395 (K151221)Kub Technologies, Inc.2015-06-23
1717SGN / 1717SCN Digital Flat Panel X-ray Detector (K150150)Rayence Co., Ltd.2015-03-27
Universal Digital Interface 2W, UDI 2W (K143232)Meridian Medical Systems, LLC2015-01-30
RIS500 (K143000)Ray Co., Ltd.2015-01-23
EVS 4343 (K142475)DRTECH Corporation2015-01-15
Radlink GPS (K142718)Radlink, Inc.2014-12-17
PerkinElmer, XRpad 4343 F MED Flat Panel Detector (K142698)Perkinelmer, Inc.2014-10-23
UNIVERSAL DIGITAL INTERFACE 2, UDI 2 (K140251)Meridian Medical Systems, LLC2014-10-22
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (K142003)Fujifilm Medical System U.S.A., Inc.2014-10-21
DX-D IMAGING PACKAGE (K142184)Agfa Healthcare N.V.2014-10-16
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT (K141743)Radiology Solutions, LLC2014-10-03
FDR D-EVO FLAT PANEL DETECTOR SYSTEM (K141765)Fujifilm Medical Systems U.S.A, Inc.2014-10-03
AERODR SYSTEM 2 (K141271)Konica Minolta, Inc.2014-09-26
DX-D IMAGING PACKAGE (K141602)Agfa Healthcare N.V.2014-09-12
DICOMPACS DX-R WITH FLAT PANEL (K141440)Oehm Und Rehbein GmbH2014-08-29
OPAL CHIRO, 20/20 P-DR (K141435)2020 Imaging2014-08-27
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR (K140551)Perkinelmer, Inc.2014-08-01
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST (K141736)Philips Medical Systems Dmc GmbH2014-07-25
DELWORKS DR SYSTEM (K140825)Del Medical, Inc.2014-07-17
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC (K141563)Rayence Co., Ltd.2014-07-16
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC (K141566)Rayence Co., Ltd.2014-07-16
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS (K133693)Canon, Inc.2014-07-01
DR 400 (K141192)Agfa Healthcare N.V.2014-06-06
XGEO GR40CW (K140235)Samsung Electronics Co., Ltd.2014-05-15
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A (K140060)Rayence Co., Ltd.2014-05-13
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A (K140056)Rayence Co., Ltd.2014-05-13
PHILIPS ELEVA WORKSPOT (K140771)Philips Medical Systems Dmc GmbH2014-04-25
PVMED DDR 2430T (K133524)Portavision Medical, LLC2014-04-16
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G (K140646)Rayence Co., Ltd.2014-04-11
VIZION ULTRA (K133139)Viztek, LLC2014-04-03
NOVA FA DR SYSTEM (K133782)Sedecal., Sa.2014-03-21
BONE SUPPRESSION SOFTWARE (K133442)Carestream Health, Inc.2014-03-11
FLAATZ 600 SERIES (FLAATZ 600/601) (K132842)Drtech Corp.2014-02-21
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA (K133409)Rayence Co., Ltd.2014-02-21
GALAXY PLUS (K132921)Medien International Co, Ltd.2014-01-17
COMPUTED RADIOGRAPHY SCANNER (K133120)3Disc Americas2014-01-15
COMPUTED RADIOGRAPHY SCANNER (K133106)3Disc Americas2014-01-15
FDR D-EVO FLAT PANEL DETECTOR SYSTEM (K132509)Fujifilm Medical Systems U.S.A, Inc.2013-11-25
DICOMPACS DX-R WITH FLAT PANEL (K131211)Oehm Und Rehbein GmbH2013-11-05
PHILIPS PIXIUM 4343RC (K131483)Philips Medical Systems Dmc GmbH2013-10-07
DIGITAL FLAT PANEL X-RAY DETECTOR (K131114)Rayence Co., Ltd.2013-09-17
CR 12-X DIGITIZER (K131408)Agfa Healthcare N.V.2013-08-29
AERODR SYSTEM WITH P-31 (K130936)Konica Minolta Medical & Graphic, Inc.2013-08-22
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, (K131106)Canon, Inc.2013-07-03
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA (K130935)Rayence Co., Ltd.2013-07-02
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) (K131314)Swissray Medical AG2013-06-25
DR LONG LENGTH IMAGING SOFTWARE (K130567)Carestream Health, Inc.2013-06-11
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR (K130464)Carestream Health, Inc.2013-06-07
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (K130377)Medicatech USA2013-05-17
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T (K130883)Sedecal., Sa.2013-04-18
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA (K123345)Rayence Co., Ltd.2013-03-12
DX-D IMAGING PACKAGE (K122736)Agfa Healthcare N.V.2013-03-11
EOS (K123740)Eos Imaging2013-02-22
VIVIX-S WIRELESS (K122865)Vieworks Co., Ltd.2013-02-01
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA (K122928)Rayence Co., Ltd.2013-01-30
VIVIX-S WITH VXVUE (K122866)Vieworks Co., Ltd.2013-01-11
VIZION + DR (K123644)Viztek, LLC2013-01-11
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA (K122919)Rayence Co., Ltd.2013-01-01
AEROPILOT (K123499)Konica Minolta Medical & Graphic, Inc.2012-12-20
DDRVERSA MOTION (K123005)Swissray Medical AG2012-12-07
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR (K122495)Perkinelmer, Inc.2012-11-28
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC (K122173)Rayence Co., Ltd.2012-10-19
RADREX-I, SW V4.00 MODEL DRAD-3000E (K122842)Toshiba America Medical Systems, In.C2012-10-09
FDR GO FLEX (K120629)Fujifilm Medical System U.S.A., Inc.2012-08-28
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC (K122182)Rayence Co., Ltd.2012-08-16
DX-D IMAGING PACKAGE (K121095)Agfa Healthcare N.V.2012-08-16
CR 10-X DIGITIZER (K121948)Agfa Healthcare N.V.2012-07-20
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM (K121838)Liebel-Flarsheim2012-07-11
FUSION FLAT PANEL (K113449)Icrco, Inc.2012-06-14
UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (K112527)Meridian Medical Systems, LLC2012-05-22
EZSENSOR P DIGITAL INTRAORAL SENSOR (K121132)Humanray Co,Ltd2012-05-10
VIVIX-S (K120020)Vieworks Co., Ltd.2012-05-04
ATAL-8 (K113812)Atlaim2012-05-03
FLAT PANEL DETECTOR (K111824)Canon Inc. -Medical Equipment Group2012-04-23
CLEARVISION DR 7000F (K102327)Jpi Healthcare Co, Ltd.2012-04-13
AEROSYNC FOR AERODR SYSTEM (K120477)Konica Minolta Medical & Graphic, Inc.2012-04-09
EOS (K120721)Eos Imaging2012-04-06
SATURN 8000 (K120380)New Medical Co., Ltd.2012-03-09
REGIUS SIGMA2 (K120131)Konica Minolta Medical & Graphic, Inc.2012-02-10
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W (K111305)Meridian Medical Systems, LLC2012-01-31
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA (K113630)Rayence Co., Ltd.2011-12-29
SDX-4343CS (K112751)Samsung Mobile Display Co., Ltd.2011-11-23
INFINIX-CCI (K113052)Toshiba America Medical Systems, In.C2011-11-22
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (K112132)Medicatech USA2011-11-18
DIGITAL FLAT PANEL X-RAY DETECTOR (K112558)Samsung Mobile Display Co., Ltd.2011-11-10
VIZION DR (K112661)Viztek, LLC2011-10-20
DIGIVIEW 250 (K103348)Kub Technologies, Inc.2011-10-20
FLAATZ 560 (K111583)Drtech Corp.2011-10-04
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE (K111865)Fujifilm Medical System U.S.A., Inc.2011-09-30
DIGITAL RADIOGRAPHY (K111682)Canon Inc. -Medical Equipment Group2011-09-02
DIGITAL RADIOGRAPHY (K112309)Canon Inc. -Medical Equipment Group2011-09-02
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE (K111548)Fujifilm Medical System U.S.A., Inc.2011-08-30
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM (K110801)Direct Digital Imaging Technology (Beijing), Inc.2011-08-02
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