510(k) Report

Devices descending from K021829

2 later devices reach Modification to Kodak Directview CR 800/900 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073670Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260Orex Computed Radiography, Ltd.20081—
+2K192894Vita Flex CR System with LLICarestream Health, Inc.20200—