510(k) Report

Devices descending from K142897

5 later devices reach P200DTx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+1K190732P200TxEOptos Plc.20190—
+1K173707P200TEOptos Plc.20183—
+2K231673P200TE (A10700)Optos Plc.20231—
+3K233602P200TE (A10700)Optos Plc.20240—