510(k) Report

Devices descending from K981640

14 later devices reach S2LO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983999PANORAMIC200 OpthalmoscopeOptos Plc.199913—
+2K111531RHA2020Annidis Health Systems Corp.20110—
+2K100644Optos Limited Panoramic 200CAFOptos Plc.20109—
+2K042001Panoramic 200AOptos Plc.20049—
+3K111628P200TOptos Plc.20110—
+3K102492P200MAAFOptos Plc.20107—
+3K060424Panoramic, Model 200MAOptos Plc.20068—
+4K142897P200DTxOptos Plc.20155—
+4K112880Clearpath DS-120(R) Lens Fluorescence BiomicroscopeFreedom Meditech, Inc.20130—
+5K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+5K190732P200TxEOptos Plc.20190—
+5K173707P200TEOptos Plc.20183—
+6K231673P200TE (A10700)Optos Plc.20231—
+7K233602P200TE (A10700)Optos Plc.20240—