510(k) Report

Devices descending from K000112

3 later devices reach Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C, A10402… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091186Kodak 1500 Intraoral CameraCarestream Health, Inc.20091—
+1K041805Microscope SystemMiras Mirror Imaging Solutions, Ltd.20040—
+2K111423CS 1600 Intraoral CameraCarestream Health, Inc.20120—