510(k) Report

Devices descending from K081648

91 later devices reach Digital Radiography Cxdi-60G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103348Digiview 250Kub Technologies, Inc.20110—
+1K091545Digital Radiography Cxdi-60CCanon, Inc.200982—
+1K083645Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc.20096—
+2K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20133—
+2K111312SanteviewSehyun Co., Ltd.20110—
+2K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+2K102012Digital RadiographyCanon Inc. -Medical Equipment Group2010801
+3K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+3K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+3K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc.201321—
+3K113855Panorad, Panorad SLImix Adr Finland OY20120—
+3K112309Digital RadiographyCanon Inc. -Medical Equipment Group201122—
+3K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.201152—
+3K103591Digital RadiographyCanon Inc. -Medical Equipment Group201124—
+3K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.201154—
+4K241980!M1Solutions For Tomorrow AB20251—
+4K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+4K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc.201715—
+4K142718Radlink GPSRadlink, Inc.20141—
+4K133693Digital Radiography Cxdi-401C WirelessCanon, Inc.20146—
+4K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201350—
+4K120629FDR GO FlexFujifilm Medical System U.S.A., Inc.20120—
+4K111865Wired/ Wireless FDR D-Evo with X-Ray Detection FeatureFujifilm Medical System U.S.A., Inc.20110—
+4K111682Digital RadiographyCanon Inc. -Medical Equipment Group20113—
+5K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+5K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+5K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20225—
+5K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc.20222—
+5K212269Intelligent NRCanon, Inc.20210—
+5K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc.20213—
+5K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc.20193—
+5K173517RADspeed fitShimadzu Corporation20181—
+5K171270Digital Radiography Cxdi-410C WirelessCanon, Inc.20172—
+5K142003FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.201416—
+5K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201432—
+6K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+6K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+6K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+6K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+6K221620Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20221—
+6K220518Skanrad 400Skanray Technologies Limited20220—
+6K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20222—
+6K203849General Radiography CXDI-CS01Canon, Inc.20212—
+6K200668DR-ID 1200SDK SystemFujifilm Corporation20200—
+6K192932FDR D-EVO III flat panel detector systemFujifilm Corporation20190—
+6K192440FDR SE LiteFujifilm Corporation20190—
+6K191939Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20199—
+6K163157SmartGridCarestream Health20171—
+6K162344Innolux RicInnolux Corporation20161—
+6K160997GC85ASamsung Electronics Co., Ltd.201626—
+6K153464FDR D-EVO flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.20162—
+6K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.20150—
+7K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—
+7K222687Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20220—
+7K222661Digital Radiography CXDI-CS01Canon, Inc.20221—
+7K221876Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20221—
+7K201528Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20207—
+7K201591Flat Panel DetectorKa Imaging, Inc.20200—
+7K180667SmartGridCarestream Health, Inc.20180—
+7K172229GC85ASamsung Electronics Co., Ltd.201721—
+7K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+7K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…Fujifilm Medical Systems U.S.A, Inc.20170—
+7K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170—
+7K163115GC70Samsung Electronics Co., Ltd.201623—
+7K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+8K230175Digital Radiography CXDI-CS01Canon, Inc.20230—
+8K222855Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20220—
+8K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+8K181629GC85ASamsung Electronics Co., Ltd.20185—
+8K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+8K171119GM85Samsung Electronics Co., Ltd.2017221
+9K260481GC85ASamsung Electronics Co., Ltd.20260—
+9K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+9K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+9K182647GC70Samsung Electronics Co., Ltd.20180—
+9K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+9K181631GR40CWSamsung Electronics Co., Ltd.20185—
+9K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+9K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+10K220175GM85Samsung Electronics Co., Ltd.20223—
+10K203188ADDH&abyz Co., Ltd.20213—
+10K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+11K222353GM85Samsung Electronics Co., Ltd.202223
+11K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+11K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+12K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+12K242651GM85Samsung Electronics Co., Ltd.20240—
+12K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+13K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+13K251443PROMODRGEM Corporation20250—
+13K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—