510(k) Report

Devices descending from K051258

32 later devices reach Kodak Directview DR 7500 System, Model 8791345 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133695TITAN 11Gemss Medical Systems Co., Ltd.20140—
+1K091889DRX-Evolution, Model VX3733-SysCarestream Health, Inc.2009303
+2K141837DRX-EvolutionCarestream Health, Inc.2015291
+3K201825MiniCAT 2DXoran Technologies, LLC20200—
+3K191879DRX-Evolution with Carestream Digital TomosynthesisCarestream Health, Inc.20190—
+3K160997GC85ASamsung Electronics Co., Ltd.201626—
+4K172229GC85ASamsung Electronics Co., Ltd.201721—
+4K163115GC70Samsung Electronics Co., Ltd.201623—
+4K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+5K181629GC85ASamsung Electronics Co., Ltd.20185—
+5K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+5K171119GM85Samsung Electronics Co., Ltd.2017221
+6K260481GC85ASamsung Electronics Co., Ltd.20260—
+6K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+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—
+6K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+7K220175GM85Samsung Electronics Co., Ltd.20223—
+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—