510(k) Report

Devices descending from K924459

194 later devices reach Digiscan 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K112670DX-D 600Agfa Healthcare N.V.201174
+6K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+6K101042BladeviewAccogent, LLC20100—
+6K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+7K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+7K223550DMXDel Medical, Inc.20230—
+7K213479D²RS and D²RS 9090Stephanix20211—
+7K203188ADDH&abyz Co., Ltd.20213—
+7K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+7K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+7K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+7K202394EOSedgeEos Imaging202011
+7K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+7K200887AS-10Canon, Inc.20200—
+7K200418Vivix-S VWVieworks Co., Ltd.20204—
+7K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+7K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+7K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+7K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+7K180651Uroview FD IIPausch Medical GmbH20180—
+7K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+7K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+7K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+7K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20170—
+7K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+7K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+7K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+7K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+7K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+7K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+7K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+7K152639DR 600Agfa Healthcare N.V.20156—
+7K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+7K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+7K151485GenesisDornier Medtech America, Inc.20151—
+7K142718Radlink GPSRadlink, Inc.20141—
+7K133434Genesis IIDornier Medtech America, Inc.20142—
+7K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+7K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K252503Intelligent NRCanon, Inc.20260—
+8K241980!M1Solutions For Tomorrow AB20251—
+8K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+8K233920EOSedgeEos Imaging20240—
+8K233543YSIO X.preeSiemens Medical Solutions20241—
+8K231995AcuityUDRRadmedix, LLC20230—
+8K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+8K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+8K221335D²RS and D²RS 9090Stephanix20220—
+8K220871NautilusDornier Medtech America, Inc.20220—
+8K213469ValoryAgfa N.V.20210—
+8K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+8K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+8K193262DR 600 with TomosynthesisAgfa N.V.20204—
+8K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+8K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+8K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+8K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH20193—
+8K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+8K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH20171—
+8K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+8K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+9K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+9K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+9K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+9K250738YSIO X.preeSiemens Medical Solutions20250—
+9K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+9K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+9K212269Intelligent NRCanon, Inc.20210—
+9K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+9K2109851717FCCRayence Co., Ltd.20210—
+9K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH202028
+9K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+9K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+10K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+10K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+10K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+10K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+10K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+10K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+10K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+11K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+11K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+11K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+11K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+11K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+12K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+12K252649TAP2DNano-X Imaging, Ltd.20260—
+12K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+12K233532MULTIX Impact ESiemens Medical Solutions20230—
+12K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—