510(k) Report

Devices descending from K981556

443 later devices reach Canon X-Ray Digital Camera Cxdi-11 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183388JADE Mobile X-RayDRGEM Corporation20190—
+7K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+7K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+7K173517RADspeed fitShimadzu Corporation20181—
+7K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+7K173187MobileDiagnost M50Philips India Limited20170—
+7K172793SKR 3000Konica Minolta, Inc.20175—
+7K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+7K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+7K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+7K162687Paragon 2Meridian Medical Systems, LLC20160—
+7K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+7K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+7K151219Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBeijing Polycon Medical Engineering Company20150—
+7K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+7K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+7K140825Delworks DR SystemDel Medical, Inc.20147—
+7K133139Vizion UltraViztek, LLC20140—
+7K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201350—
+7K123644Vizion + DRViztek, LLC201333—
+7K120629FDR GO FlexFujifilm Medical System U.S.A., Inc.20120—
+7K111865Wired/ Wireless FDR D-Evo with X-Ray Detection FeatureFujifilm Medical System U.S.A., Inc.20110—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+8K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.20250—
+8K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+8K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+8K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+8K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+8K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)Rayence Co., Ltd.20240—
+8K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+8K2403710909FCC, 0909FCC-HSRayence Co., Ltd.20241—
+8K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH202401
+8K232082EXPD 4343SDRTECH Corporation20240—
+8K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+8K222353GM85Samsung Electronics Co., Ltd.202223
+8K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+8K221620Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20221—
+8K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20225—
+8K220518Skanrad 400Skanray Technologies Limited20220—
+8K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20222—
+8K212515MOVIX DReamyStephanix20210—
+8K212291PhoenixSedecal., Sa.202141
+8K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+8K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+8K203703I-Q ViewFirst Source, Inc.20210—
+8K203849General Radiography CXDI-CS01Canon, Inc.20212—
+8K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+8K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+8K192936Soltus 500Sedecal., Sa.201901
+8K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+8K182688SKR 3000Konica Minolta, Inc.20184—
+8K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+8K171119GM85Samsung Electronics Co., Ltd.2017221
+8K170975Televere Digital Imaging SystemTelevere Systems20172—
+8K152279ViZion DR + WirelessViztek, LLC201527—
+8K142003FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.201416—
+8K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201432—
+8K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+9K2538000909FCE, 0909FCE-HSRayence Co., Ltd.20260—
+9K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+9K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+9K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+9K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+9K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+9K242651GM85Samsung Electronics Co., Ltd.20240—
+9K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+9K232185SM-IVSedecal., Sa.20230—
+9K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+9K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+9K222951SM-VSedecal., Sa.20221—
+9K222687Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20220—
+9K222661Digital Radiography CXDI-CS01Canon, Inc.20221—
+9K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+9K221876Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20221—
+9K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+9K210619SKR 3000Konica Minolta, Inc.20212—
+9K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+9K200726AcuityPDRRadmedix, LLC20209—
+9K200668DR-ID 1200SDK SystemFujifilm Corporation20200—
+9K192932FDR D-EVO III flat panel detector systemFujifilm Corporation20190—
+9K192440FDR SE LiteFujifilm Corporation20190—
+9K191939Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20199—
+9K191645SKR 4000Konica Minolta, Inc.20190—
+9K181629GC85ASamsung Electronics Co., Ltd.20185—
+9K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+9K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+9K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+9K163157SmartGridCarestream Health20171—
+9K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+9K160997GC85ASamsung Electronics Co., Ltd.201626—
+9K160810ViZion DR + WirelessViztek, LLC20161—
+9K153464FDR D-EVO flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.20162—
+9K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.20150—
+10K260481GC85ASamsung Electronics Co., Ltd.20260—
+10K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+10K252649TAP2DNano-X Imaging, Ltd.20260—
+10K251443PROMODRGEM Corporation20250—
+10K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—
+10K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—