510(k) Report

Devices descending from K180809

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202441Eclipse II with Smart Noise CancellationCarestream Health, Inc.20211—
+2K213307Eclipse II with Smart Noise CancellationCarestream Health, Inc.20220—