510(k) Report

Devices descending from K062742

6 later devices reach CR 85-X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072010Quantum Direx SystemQuantum Medical Imaging, LLC20075—
+2K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC20084—
+3K193574Q-Rad SystemCarestream Health, Inc.20203—
+4K201373DRX-CompassCarestream Health, Inc.202021
+5K223842DRX - CompassCarestream Health, Inc.20231—
+6K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—