510(k) Report

Devices descending from K151685

20 later devices reach GUA60A, GU60A-65 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+2K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+3K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+3K182647GC70Samsung Electronics Co., Ltd.20180—
+3K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+3K181631GR40CWSamsung Electronics Co., Ltd.20185—
+3K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+4K220175GM85Samsung Electronics Co., Ltd.20223—
+4K203188ADDH&abyz Co., Ltd.20213—
+4K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+5K222353GM85Samsung Electronics Co., Ltd.202223
+5K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+5K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+6K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+6K242651GM85Samsung Electronics Co., Ltd.20240—
+6K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+6K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+7K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+7K251443PROMODRGEM Corporation20250—
+7K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—