510(k) Report

Devices descending from K003945

2 later devices reach Opdima through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072392Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc.20070—
+1K071015Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc.20071—