510(k) Report

Devices descending from K183292

4 later devices reach Topaz Mobile DR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+2K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+3K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+3K251443PROMODRGEM Corporation20250—