510(k) Report

Devices descending from K071162

38 later devices reach Agfa Computed Radiography System with NX2.X Workstations through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081963Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation200837—
+2K090672Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V.2009362
+3K122736DX-D Imaging PackageAgfa Healthcare N.V.201325—
+3K092669DX-D Imaging PackageAgfa Healthcare N.V.2009341
+3K092238Agfa Computed Radiography Systems with DX-G DigitizersAgfa Healthcare N.V.200912
+4K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—
+4K141192DR 400Agfa Healthcare N.V.20147—
+4K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+4K121095DX-D Imaging PackageAgfa Healthcare N.V.20123—
+4K103597DX-D 100Agfa Healthcare N.V.201116
+4K103050DX-D 300Agfa Healthcare N.V.20108—
+5K203188ADDH&abyz Co., Ltd.20213—
+5K191884DR 100sAgfa N.V.20190—
+5K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+5K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+5K152639DR 600Agfa Healthcare N.V.20156—
+5K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+5K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+5K112670DX-D 600Agfa Healthcare N.V.201174
+6K213469ValoryAgfa N.V.20210—
+6K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+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—
+6K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+7K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+7K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+7K212269Intelligent NRCanon, Inc.20210—
+7K2109851717FCCRayence Co., Ltd.20210—
+7K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH202028
+7K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+8K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+8K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+8K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+9K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+9K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+10K252649TAP2DNano-X Imaging, Ltd.20260—