510(k) Report

Devices descending from K181594

8 later devices reach Spectralis HRA+OCT and variants with OCT Angiography Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+2K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+3K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+4K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+5K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+5K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+6K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+6K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—