510(k) Report

Devices descending from K152205

14 later devices reach Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH201713—
+2K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+2K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH20180—
+2K180526Eidon FACentervue S.P.A.20182—
+3K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+3K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+4K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+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—