510(k) Report

Devices descending from K153080

16 later devices reach RTVue XR OCT Avanti with AngioVue Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182942Canon OCT-A1Canon, Inc.20190—
+1K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+1K180660AvantiOptovue, Inc.20185—
+2K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+2K222166SOLIXOptovue, Inc.20221—
+2K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+2K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+3K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+3K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—
+3K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+4K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+5K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+6K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+6K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+7K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+7K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—