510(k) Report

Devices descending from K190330

2 later devices reach DRX-Evolution/Plus with Dual Energy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233381DRX-Evolution Plus SystemCarestream Health, Inc.20241—
+2K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—