510(k) Report

Devices descending from K041701

12 later devices reach Afga CR25.0 Computed Radiography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062223Agfa Model CR30-XAgfa Corporation20068—
+1K050810Agfa CR50.0Agfa Corp.200502
+1K042779Radiotherapy Solution Based on CRAgfa Corp.20041—
+2K121948CR 10-X DigitizerAgfa Healthcare N.V.201211
+2K072010Quantum Direx SystemQuantum Medical Imaging, LLC20075—
+2K070920Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc.20070—
+3K131408CR 12-X DigitizerAgfa Healthcare N.V.20130—
+3K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC20084—
+4K193574Q-Rad SystemCarestream Health, Inc.20203—
+5K201373DRX-CompassCarestream Health, Inc.202021
+6K223842DRX - CompassCarestream Health, Inc.20231—
+7K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—