510(k) Report

Devices descending from K181626

10 later devices reach Digital Diagnostic Mobile X-ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220175GM85Samsung Electronics Co., Ltd.20223—
+1K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+1K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+2K222353GM85Samsung Electronics Co., Ltd.202223
+2K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+3K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+3K242651GM85Samsung Electronics Co., Ltd.20240—
+3K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+4K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+4K251443PROMODRGEM Corporation20250—