510(k) Report

Devices descending from K012546

158 later devices reach Optima Urs Universal Radiographic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141192DR 400Agfa Healthcare N.V.20147—
+1K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd.20080—
+1K073650Fujifilm Unity Speedsuite, Model CR-IR 371Fujifilm Medical Systems U.S.A, Inc.20080—
+1K072659Rad Vision, Models E and EUAlmana Medical Imaging20077—
+1K071193Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp.20074—
+1K062335Sedecal X Plus LP PlusSedecal., Sa.200699—
+1K042876Urs LP Digital, Millennium, RadproSedecal., Sa.2004138—
+2K152639DR 600Agfa Healthcare N.V.20156—
+2K103050DX-D 300Agfa Healthcare N.V.20108—
+2K090279Sedecal, Millennium PlusSedecal., Sa.200917—
+2K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa.200946—
+2K082604Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc.200841—
+2K082064Radvision ET Diagnostic X-Ray SystemAlmana Medical Imaging20086—
+2K080582Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FAMedicatech USA200816—
+2K073114Imix Insight X-Ray SystemsImix Adr Finland OY20082—
+2K063283Definium 5000 X-Ray SystemSedecal., Sa.2006143
+3K213469ValoryAgfa N.V.20210—
+3K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsSedecal., Sa.20210—
+3K193262DR 600 with TomosynthesisAgfa N.V.20204—
+3K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System…Konica Minolta Healthcare Americas, Inc.20202—
+3K182134ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20181—
+3K150506ELIAN Digital Diagnostic X-ray SystemOsko, Inc.20150—
+3K133782Nova FA DR SystemSedecal., Sa.2014111
+3K132294Galaxy and Galaxy+Plus Digital Radiography SystemsRadiology Solutions, LLC20131—
+3K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc.201213—
+3K121345SR Suite 1.0Halifax Biomedical, Inc.20121—
+3K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+3K112670DX-D 600Agfa Healthcare N.V.201174
+3K102123Vizion DRViztek, Inc.201136—
+3K102408Digital Diagnostic X-Ray SystemDRGEM Corporation201017—
+3K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+3K092830Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd.201018—
+3K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+3K091752Viztek WLViztek, Inc.20090—
+3K083109Suinsa Diagnostic X-Ray SystemSuinsa20085—
+3K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+4K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+4K214012Straight Arm DDRKonica Minolta Healthcare Americas, Inc.20221—
+4K202388Apolo D / Apolo SVmi Tecnologias Ltda20200—
+4K202293Radiographic System Challenge XSedecal., Sa.20200—
+4K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20200—
+4K192453Diamond-5A/6A/8ADRGEM Corporation20192—
+4K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation201911—
+4K182880Halifax Imaging KitHalifax Biomedical, Inc.20180—
+4K173953uDR 780iShanghai United Imaging Healthcare Co., Ltd.20182—
+4K150816Jumong SeriesSg Healthcare Co, Ltd.20152—
+4K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA20152—
+4K141743Fusion Digital Diagnostic X-Ray Upgrade KitRadiology Solutions, LLC20140—
+4K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc.201412—
+4K132921Galaxy PlusMedien International Co, Ltd.20140—
+4K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+4K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+4K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+4K123005Ddrversa MotionSwissray Medical AG20124—
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K113855Panorad, Panorad SLImix Adr Finland OY20120—
+4K112661Vizion DRViztek, LLC201134—
+4K111098Innovaxion FP, Innovaxion FP 1600 Plus, MagellanImaging Dynamics Company, Ltd.20110—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology201017—
+5K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+5K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+5K241068uDR 780iShanghai United Imaging Healthcare Co., Ltd.20241—
+5K230800Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50Gemss Healthcare CO., LTD.20230—
+5K230918MasterX 800 SeriesMedicatech USA20230—
+5K230241Jumong GeneralSg Healthcare Co, Ltd.20230—
+5K221853Otc DDRKonica Minolta Healthcare Americas, Inc.20220—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+5K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+5K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+5K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+5K190601MasteRad MX30Medicatech USA20190—
+5K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+5K162529DigiX FDXAllengers Medical Systems Limited20176—
+5K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+5K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K151219Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBeijing Polycon Medical Engineering Company20150—
+5K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+5K142475EVS 4343DRTECH Corporation201513—
+5K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+5K140825Delworks DR SystemDel Medical, Inc.20147—
+5K141381DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd.201437
+5K133139Vizion UltraViztek, LLC20140—
+5K123644Vizion + DRViztek, LLC201333—
+5K122173Digital Flat Planel X-Ray Detector / 1717SCCRayence Co., Ltd.20120—
+5K122182Digital Flat Panel X-Ray Detector/1717SGCRayence Co., Ltd.20121—
+6K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.20250—
+6K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+6K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+6K242119Innovision-ExiiDk Medical System20252—
+6K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+6K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+6K203703I-Q ViewFirst Source, Inc.20210—
+6K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd.202002
+6K192541DigiX FDXAllengers Medical Systems Limited20195—
+6K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—