510(k) Report

Devices descending from K982196

221 later devices reach Digital Radiographic Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+5K141192DR 400Agfa Healthcare N.V.20147—
+5K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+5K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+5K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+5K123526Clearread +ConfirmRiverain Technologies201225—
+5K113855Panorad, Panorad SLImix Adr Finland OY20120—
+5K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+5K112670DX-D 600Agfa Healthcare N.V.201174
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+6K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K233719FDR Visionary SuiteShimadzu Corporation20240—
+6K233722RADspeed ProShimadzu Corporation202401
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+6K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K212690qXR-BTQure.Ai Technologies20210—
+6K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+6K203188ADDH&abyz Co., Ltd.20213—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K200418Vivix-S VWVieworks Co., Ltd.20204—
+6K193262DR 600 with TomosynthesisAgfa N.V.20204—
+6K200018HAD1717MCH&Abyz20200—
+6K190373SonialVision G4Shimadzu Corporation201942
+6K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+6K182647GC70Samsung Electronics Co., Ltd.20180—
+6K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+6K18234814HK701G-WLg Electronics.Inc20187—
+6K182234Optima XR240amxGe Medical Systems, LLC201812
+6K181631GR40CWSamsung Electronics Co., Ltd.20185—
+6K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+6K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+6K18033217HK700G-WLg Electronics20188—
+6K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+6K173517RADspeed fitShimadzu Corporation20181—
+6K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+6K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+6K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+6K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20170—
+6K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+6K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+6K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+6K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+6K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+6K160997GC85ASamsung Electronics Co., Ltd.201626—
+6K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+6K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+6K153401GR40CWSamsung Electronics Co., Ltd.201520—
+6K152639DR 600Agfa Healthcare N.V.20156—
+6K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+6K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+6K142718Radlink GPSRadlink, Inc.20141—
+6K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K252133Adaptix Ortho350Adaptix Limited20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K241980!M1Solutions For Tomorrow AB20251—
+7K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+7K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+7K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+7K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+7K22146110HQ701G-BLg Electronics.Inc20220—
+7K22139414HQ701G-BLg Electronics.Inc20221—
+7K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+7K22143417HQ701G-BLg Electronics.Inc20220—
+7K220175GM85Samsung Electronics Co., Ltd.20223—
+7K220518Skanrad 400Skanray Technologies Limited20220—
+7K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+7K213469ValoryAgfa N.V.20210—
+7K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+7K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+7K210982AMX NavigateGe Medical Systems, LLC202101
+7K191877FLUOROspeedShimadzu Corporation201902
+7K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+7K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+7K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH20193—
+7K18328617HK701G-WLg Electronics.Inc20182—
+7K172229GC85ASamsung Electronics Co., Ltd.201721—
+7K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH20171—
+7K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+7K171119GM85Samsung Electronics Co., Ltd.2017221
+7K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+7K163115GC70Samsung Electronics Co., Ltd.201623—
+7K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+8K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+8K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+8K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+8K22354614HQ721G-BLg Electronics.Inc20230—
+8K221281Multitom RaxSiemens Medical Solutions202201
+8K222353GM85Samsung Electronics Co., Ltd.202223
+8K21404414HQ901G-BLg Electronics.Inc20221—
+8K212269Intelligent NRCanon, Inc.20210—
+8K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+8K2109851717FCCRayence Co., Ltd.20210—