510(k) Report

Devices descending from K053634

46 later devices reach Computed Radiography System with NX 1.0 Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072010Quantum Direx SystemQuantum Medical Imaging, LLC20075—
+1K071162Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp.2007382
+1K063421DX-SIAgfa Corp.20066—
+2K081963Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation200837—
+2K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC20084—
+3K193574Q-Rad SystemCarestream Health, Inc.20203—
+3K090672Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V.2009362
+4K201373DRX-CompassCarestream Health, Inc.202021
+4K122736DX-D Imaging PackageAgfa Healthcare N.V.201325—
+4K092669DX-D Imaging PackageAgfa Healthcare N.V.2009341
+4K092238Agfa Computed Radiography Systems with DX-G DigitizersAgfa Healthcare N.V.200912
+5K223842DRX - CompassCarestream Health, Inc.20231—
+5K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—
+5K141192DR 400Agfa Healthcare N.V.20147—
+5K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+5K121095DX-D Imaging PackageAgfa Healthcare N.V.20123—
+5K103597DX-D 100Agfa Healthcare N.V.201116
+5K103050DX-D 300Agfa Healthcare N.V.20108—
+6K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+6K203188ADDH&abyz Co., Ltd.20213—
+6K191884DR 100sAgfa N.V.20190—
+6K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+6K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+6K152639DR 600Agfa Healthcare N.V.20156—
+6K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+6K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+6K112670DX-D 600Agfa Healthcare N.V.201174
+7K213469ValoryAgfa N.V.20210—
+7K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+7K193262DR 600 with TomosynthesisAgfa N.V.20204—
+7K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+7K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH20193—
+7K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH20171—
+7K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+8K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+8K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+8K212269Intelligent NRCanon, Inc.20210—
+8K2109851717FCCRayence Co., Ltd.20210—
+8K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH202028
+8K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+9K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+9K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+9K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+10K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+10K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+11K252649TAP2DNano-X Imaging, Ltd.20260—