510(k) Report

Devices descending from K993861

82 later devices reach Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052661Quix Digital Radiographic UpgradeEdge Medical Devices, Ltd.20060—
+1K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc.200378—
+1K013218Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc.200111
+2K120020Vivix-SVieworks Co., Ltd.201230—
+2K111312SanteviewSehyun Co., Ltd.20110—
+2K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+2K092669DX-D Imaging PackageAgfa Healthcare N.V.2009341
+2K083645Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc.20096—
+2K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+2K072766Pvmed DDR 2520 Digital Imaging SystemPortavision Medical20070—
+3K132847I2CIon Beam Applications S.A.201303
+3K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20133—
+3K122736DX-D Imaging PackageAgfa Healthcare N.V.201325—
+3K122865Vivix-S WirelessVieworks Co., Ltd.201328—
+3K122866Vivix-S with VxvueVieworks Co., Ltd.201311—
+3K121095DX-D Imaging PackageAgfa Healthcare N.V.20123—
+3K103597DX-D 100Agfa Healthcare N.V.201116
+3K103050DX-D 300Agfa Healthcare N.V.20108—
+3K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+3K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+4K191884DR 100sAgfa N.V.20190—
+4K181789VeriSuiteMedcom GmbH20180—
+4K162344Innolux RicInnolux Corporation20161—
+4K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+4K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+4K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.201512—
+4K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+4K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—
+4K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+4K141192DR 400Agfa Healthcare N.V.20147—
+4K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+4K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+4K113855Panorad, Panorad SLImix Adr Finland OY20120—
+4K112670DX-D 600Agfa Healthcare N.V.201174
+5K203188ADDH&abyz Co., Ltd.20213—
+5K200418Vivix-S VWVieworks Co., Ltd.20204—
+5K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+5K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+5K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+5K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20170—
+5K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+5K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+5K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+5K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+5K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+5K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+5K152639DR 600Agfa Healthcare N.V.20156—
+5K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+5K142718Radlink GPSRadlink, Inc.20141—
+5K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+6K241980!M1Solutions For Tomorrow AB20251—
+6K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+6K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+6K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+6K213469ValoryAgfa N.V.20210—
+6K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+6K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+6K193262DR 600 with TomosynthesisAgfa N.V.20204—
+6K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+6K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH20193—
+6K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH20171—
+6K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+6K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+7K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+7K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+7K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+7K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+7K212269Intelligent NRCanon, Inc.20210—
+7K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+7K2109851717FCCRayence Co., Ltd.20210—
+7K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH202028
+7K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+8K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+8K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+8K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+8K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+8K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+9K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+9K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+9K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+10K252649TAP2DNano-X Imaging, Ltd.20260—
+10K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—