510(k) Report

Devices descending from K120238

17 later devices reach Rtvue XR Oct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.201616—
+2K182942Canon OCT-A1Canon, Inc.20190—
+2K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+2K180660AvantiOptovue, Inc.20185—
+3K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+3K222166SOLIXOptovue, Inc.20221—
+3K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+3K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+4K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+4K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—
+4K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+5K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+6K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+7K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+7K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+8K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+8K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—