510(k) Report

Devices descending from K153401

20 later devices reach GR40CW through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+1K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+2K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+2K182647GC70Samsung Electronics Co., Ltd.20180—
+2K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+2K181631GR40CWSamsung Electronics Co., Ltd.20185—
+2K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+3K220175GM85Samsung Electronics Co., Ltd.20223—
+3K203188ADDH&abyz Co., Ltd.20213—
+3K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+4K222353GM85Samsung Electronics Co., Ltd.202223
+4K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+4K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+5K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+5K242651GM85Samsung Electronics Co., Ltd.20240—
+5K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+5K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+6K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+6K251443PROMODRGEM Corporation20250—
+6K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—