510(k) Report

Devices descending from K120057

6 later devices reach Envisu Spectral Domain Ophthalmic Imaging System (Sdois) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+1K150722EnFocus 2300, EnFocus 4400Bioptigen, Inc.20151—
+1K142953OCT-CameraOptomedical Technologies GmbH201512
+2K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+2K200516OCT-Camera ID 21101A3Optomedical Technologies GmbH20200—
+2K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc.20160—