510(k) Report

Devices descending from K181345

1 later device reach Image Filing Software NAVIS-EX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—