510(k) Report

Devices descending from K182569

7 later devices reach Spectralis HRA+OCT and variants with High Magnification Module through their predicates, nearest generation first.

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