510(k) Report

Devices descending from K941234

121 later devices reach Non-Mydriatic Retinal Camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+7K181501AfinaNeurovision Imaging, LLC20180—
+7K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+7K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH20180—
+7K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+8K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+8K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.20250—
+8K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+8K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+8K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+8K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+8K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+9K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+9K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+9K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+10K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+11K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+12K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+12K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+13K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+13K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—