510(k) Report

Devices descending from K201124

3 later devices reach TOPAZ Mobile DR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+2K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+2K251443PROMODRGEM Corporation20250—