510(k) Report

Devices descending from P080018

2 later devices reach Kodak Directview Computed Radiography (CR) Mammography through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120246Kodak Directview CR Mammography System (Using Carestream CR Mammography Cassette with…Carestream Health, Inc.20120—
+1K111646Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General…Fujifilm Medical System U.S.A., Inc.20110—