510(k) Report

Devices descending from K090318

79 later devices reach Carestream DRX-1 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130464Carestream DRX-1 System with DRX 2530C DetectorCarestream Health, Inc.201317—
+1K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130—
+1K100762Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc.201055—
+1K091889DRX-Evolution, Model VX3733-SysCarestream Health, Inc.2009303
+2K150766Carestream DRX-1 SystemCarestream Health, Inc.201516—
+2K141837DRX-EvolutionCarestream Health, Inc.2015291
+2K120629FDR GO FlexFujifilm Medical System U.S.A., Inc.20120—
+2K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.201154—
+3K203159Lux 35 DetectorCarestream Health20201—
+3K201825MiniCAT 2DXoran Technologies, LLC20200—
+3K191879DRX-Evolution with Carestream Digital TomosynthesisCarestream Health, Inc.20190—
+3K183245Carestream DRX-1 System with DRX Plus 2530 DetectorsCarestream Health, Inc.20191—
+3K162555Evs 4343, Evs 4343GDRTECH Corporation20167—
+3K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+3K160997GC85ASamsung Electronics Co., Ltd.201626—
+3K153142Carestream DRX-1 System with DRX Plus 4343 DetectorsCarestream Health, Inc.20151—
+3K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201350—
+3K111865Wired/ Wireless FDR D-Evo with X-Ray Detection FeatureFujifilm Medical System U.S.A., Inc.20110—
+3K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.201152—
+4K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health20260—
+4K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20225—
+4K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+4K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+4K172229GC85ASamsung Electronics Co., Ltd.201721—
+4K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+4K163115GC70Samsung Electronics Co., Ltd.201623—
+4K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+4K142003FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.201416—
+4K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201432—
+5K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+5K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+5K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+5K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+5K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+5K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+5K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+5K200668DR-ID 1200SDK SystemFujifilm Corporation20200—
+5K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+5K192932FDR D-EVO III flat panel detector systemFujifilm Corporation20190—
+5K192440FDR SE LiteFujifilm Corporation20190—
+5K191939Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20199—
+5K181629GC85ASamsung Electronics Co., Ltd.20185—
+5K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+5K171119GM85Samsung Electronics Co., Ltd.2017221
+5K163157SmartGridCarestream Health20171—
+5K162344Innolux RicInnolux Corporation20161—
+5K153464FDR D-EVO flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.20162—
+5K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.20150—
+6K260481GC85ASamsung Electronics Co., Ltd.20260—
+6K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—
+6K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+6K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+6K232082EXPD 4343SDRTECH Corporation20240—
+6K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+6K201528Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20207—
+6K201591Flat Panel DetectorKa Imaging, Inc.20200—
+6K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+6K182647GC70Samsung Electronics Co., Ltd.20180—
+6K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+6K181631GR40CWSamsung Electronics Co., Ltd.20185—
+6K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+6K180667SmartGridCarestream Health, Inc.20180—
+6K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+6K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+6K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…Fujifilm Medical Systems U.S.A, Inc.20170—
+6K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170—
+7K220175GM85Samsung Electronics Co., Ltd.20223—
+7K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+7K203188ADDH&abyz Co., Ltd.20213—
+7K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+8K222353GM85Samsung Electronics Co., Ltd.202223
+8K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+8K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+9K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+9K242651GM85Samsung Electronics Co., Ltd.20240—
+9K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+10K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+10K251443PROMODRGEM Corporation20250—
+10K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—