510(k) Report

Devices descending from K242015

2 later devices reach TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+1K251443PROMODRGEM Corporation20250—