510(k) Report

Devices descending from K090326

7 later devices reach Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated20181—
+1K102859Retcam 3 Opthalmic Imaging SystemClarity Medical Systems201142
+2K203500RetCam EnvisionNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20210—
+2K1830593nethra neoForus Health Pvt.Ltd20181—
+2K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical20173—
+3K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd20250—
+3K223575Phoenix ICON, Phoenix ICON GONeolight, LLC20230—