510(k) Report

Devices descending from K973206

153 later devices reach Sterling Diagnostic Imaging Direct Radiography through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K112670DX-D 600Agfa Healthcare N.V.201174
+5K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+5K071430Synerad Omni, Models AN6255 and AN6265Analogic Corp.20070—
+6K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+6K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH202401
+6K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K212269Intelligent NRCanon, Inc.20210—
+6K203703I-Q ViewFirst Source, Inc.20210—
+6K200418Vivix-S VWVieworks Co., Ltd.20204—
+6K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—
+6K191504PowerDRRadiology Information Systems, Inc.20190—
+6K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+6K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+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—
+6K162990Optima XR240amxGe Medical Systems, LLC201632
+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—
+6K152639DR 600Agfa Healthcare N.V.20156—
+6K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+6K142718Radlink GPSRadlink, Inc.20141—
+7K241980!M1Solutions For Tomorrow AB20251—
+7K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+7K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+7K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+7K213469ValoryAgfa N.V.20210—
+7K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+7K193262DR 600 with TomosynthesisAgfa N.V.20204—
+7K173602Optima XR240amx, AutoGridGe Medical Systems, LLC201822
+7K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+7K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+8K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+8K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+8K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+8K182234Optima XR240amxGe Medical Systems, LLC201812
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+9K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+9K210982AMX NavigateGe Medical Systems, LLC202101
+9K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+10K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+10K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+11K252649TAP2DNano-X Imaging, Ltd.20260—
+11K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—