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Panels › Radiology › Product code KPR · Class 2

System, X-Ray, Stationary

Regulation 892.1680

7510(k)s in 12 months (359 all time)
3recalls in 12 months (170 all time)
160recalls that name a 510(k)
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Top companies in KPR

Company510(k)sRecalls
Siemens Medical Solutions1731
Carestream Health1111
Samsung Electronics Co., Ltd.210
GE Healthcare119
GE Medical Systems99
Imaging Dynamics Company , Ltd.110
Philips Medical Systems North America Co. Phillips011
Philips Healthcare010
Philips Medical Systems (Cleveland), Inc.81
Philips Medical Systems Dmc GmbH36
Decided510(k)Device and applicantCode
Nov 22, 2016K162971Multix Fusion Max
Siemens Medical Solutions USA, Inc.
KPR
Oct 6, 2016K161937CuattroDR
Cuattro, LLC
KPR
Sep 22, 2016K162224ArtPix Mobile EZ2GO
Cmt Medical Technologies, Ltd., IL
KPR
Jul 15, 2016K152294FDR Visionary Suite
Shimadzu Corporation, JP
KPR
Jul 6, 2016K160997GC85A
Samsung Electronics Co., Ltd., KR
KPR
Jun 20, 2016K152244RADspeed Pro
Shimadzu Corporation, JP
KPR
Mar 30, 2016K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
Visaris D.O.O. Belgrade, RS
KPR
Mar 14, 2016K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Ra
Summit Industries, LLC
KPR
Dec 14, 2015K152767OTC12D AUTO RADIOGRAPHIC SYSTEM
Del Medical, Inc.
KPR
Oct 21, 2015K152788EOS System
Eos Imaging, FR
KPR
Aug 7, 2015K151924Q-Rad Radiographic System with Auto-Tracker Option
Quantum Medical Imaging Divison of Carestream
KPR
Aug 4, 2015K151219Models 2200DR and 1600DR Digital Stationary Radiographic Systems
Beijing Polycon Medical Engineering Company, CN
KPR
Jul 17, 2015K151685GUA60A, GU60A-65
Samsung Electronics Co., Ltd., KR
KPR
Jun 23, 2015K151419GF50A
Samsung Electronics Co., Ltd., KR
KPR
Jun 8, 2015K150725Visaris Avanse
Visaris D.O.O. Belgrade, RS
KPR
May 8, 2015K150816Jumong Series
Sg Healthcare Co, Ltd., KR
KPR
May 7, 2015K150663Diagnostic X-ray System
Osko, Inc.
KPR
Apr 17, 2015K142930Exam Vue DR
Jpi Healthcare Co, Ltd., KR
KPR
Apr 8, 2015K150506ELIAN Digital Diagnostic X-ray System
Osko, Inc.
KPR
Apr 2, 2015K150165GC85A
Samsung Electronics Co., Ltd., KR
KPR
Mar 11, 2015K141837DRX-EVOLUTION
Carestream Health, Inc.
KPR
Feb 18, 2015K143270Optima XR646
Ge Hualun Medical Systems Co. , Ltd., CN
KPR
Feb 6, 2015K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System
Medicatech USA
KPR
Feb 4, 2015K143029Digital Diagnostic X-ray System (GC80)
Samsung Electronics Co., Ltd., KR
KPR
Jan 22, 2015K142773EOS System
Eos Imaging, FR
KPR
Jan 22, 2015K133959PODIATRY X-RAY SYSTEM
Source-Ray, Inc.
KPR
Dec 18, 2014K142049MULTIX FUSION VA30 & VA40
Siemens Medical Solutions USA, Inc.
KPR
Dec 3, 2014K133496X TWIN SYSTEM
Roesys GmbH, DE
KPR
Aug 7, 2014K133695TITAN 11
Gemss Medical Systems Co., Ltd.
KPR
Jun 12, 2014K141381DURADIAGNOST
Philips Healthcare (Suzhou) Co., Ltd., CN
KPR
Jun 3, 2014K1406830180 INTUITION, 0072 PRECISION
Arcoma AB
KPR
May 29, 2014K140326XGEO GF50
Samsung Electronics Co., Ltd., KR
KPR
May 28, 2014K140334XGEO GC80
Samsung Electronics Co., Ltd., KR
KPR
May 28, 2014K140332XGEO GU60A
Samsung Electronics Co., Ltd., KR
KPR
Apr 10, 2014K132934MULTIX SELECT DR
Siemens Medi Cal Solutions, Inc.
KPR
Jan 24, 2014K133259YSIO MAX
Siemens Medical Solutions USA, Inc.
KPR
Nov 12, 2013K132294GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
Radiology Solutions, LLC
KPR
Jun 20, 2013K123106DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
Samsung Electronics Co., Ltd.
KPR
Jun 7, 2013K123105XGEO GU60
Samsung Electronics Co., Ltd.
KPR
Feb 15, 2013K122726CPI RAD VISION
Communications & Power Industries Canada, Inc., CA
KPR
Jan 18, 2013K123098XGEO GC80
Samsung Electronics Co., Ltd.
KPR
Nov 20, 2012K122454FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
Fujifilm Medical System U.S.A., Inc.
KPR
Oct 5, 2012K122589DFP4343C7
Mdi Consultants, Inc.
KPR
Sep 13, 2012K122119DX-D FULL LEG FULL SPINE
Afga Healthcare N.V.
KPR
Aug 22, 2012K121854SYSTEM, X-RAY, STATIONARY
Beijing Sinopharm Hundric Mediline Info. Tech. Co., CN
KPR
Aug 10, 2012K121513MULTIX FUSION
Siemens Medical Solution
KPR
Jun 8, 2012K120752AERODR STITCHING SYSTEM
Konica Minolta Medical & Graphic, Inc.
KPR
Jun 1, 2012K121345SR SUITE 1.0
Halifax Biomedical, Inc.
KPR
May 23, 2012K121109AERODR X70
Konica Minolta Medical & Graphic, Inc., JP
KPR
Apr 17, 2012K120034RADIOGRAPHIC X-RAY SYSTEM
Orich Medical Equipment (Tianjin Co., Ltd.
KPR

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