510(k) Report

Devices descending from K862120

227 later devices reach SCX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+6K143029Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd.201501
+6K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+6K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+6K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+6K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—
+6K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+6K141192DR 400Agfa Healthcare N.V.20147—
+6K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+6K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+6K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+6K123526Clearread +ConfirmRiverain Technologies201225—
+6K113855Panorad, Panorad SLImix Adr Finland OY20120—
+6K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+6K112670DX-D 600Agfa Healthcare N.V.201174
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+7K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K233719FDR Visionary SuiteShimadzu Corporation20240—
+7K233722RADspeed ProShimadzu Corporation202401
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+7K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K212690qXR-BTQure.Ai Technologies20210—
+7K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+7K203188ADDH&abyz Co., Ltd.20213—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K200418Vivix-S VWVieworks Co., Ltd.20204—
+7K193262DR 600 with TomosynthesisAgfa N.V.20204—
+7K200018HAD1717MCH&Abyz20200—
+7K190373SonialVision G4Shimadzu Corporation201942
+7K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+7K182647GC70Samsung Electronics Co., Ltd.20180—
+7K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+7K18234814HK701G-WLg Electronics.Inc20187—
+7K182234Optima XR240amxGe Medical Systems, LLC201812
+7K181631GR40CWSamsung Electronics Co., Ltd.20185—
+7K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+7K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+7K18033217HK700G-WLg Electronics20188—
+7K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+7K173517RADspeed fitShimadzu Corporation20181—
+7K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+7K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+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—
+7K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+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—
+7K160997GC85ASamsung Electronics Co., Ltd.201626—
+7K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+7K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+7K153401GR40CWSamsung Electronics Co., Ltd.201520—
+7K152639DR 600Agfa Healthcare N.V.20156—
+7K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+7K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+7K142718Radlink GPSRadlink, Inc.20141—
+7K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K252133Adaptix Ortho350Adaptix Limited20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K241980!M1Solutions For Tomorrow AB20251—
+8K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+8K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+8K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+8K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+8K22146110HQ701G-BLg Electronics.Inc20220—
+8K22139414HQ701G-BLg Electronics.Inc20221—
+8K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+8K22143417HQ701G-BLg Electronics.Inc20220—
+8K220175GM85Samsung Electronics Co., Ltd.20223—
+8K220518Skanrad 400Skanray Technologies Limited20220—
+8K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+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—
+8K210982AMX NavigateGe Medical Systems, LLC202101
+8K191877FLUOROspeedShimadzu Corporation201902
+8K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+8K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+8K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH20193—
+8K18328617HK701G-WLg Electronics.Inc20182—
+8K172229GC85ASamsung Electronics Co., Ltd.201721—
+8K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH20171—
+8K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+8K171119GM85Samsung Electronics Co., Ltd.2017221
+8K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+8K163115GC70Samsung Electronics Co., Ltd.201623—
+8K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+9K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+9K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+9K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+9K22354614HQ721G-BLg Electronics.Inc20230—