510(k) Report

Devices descending from K171720

6 later devices reach encevis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243743autoSCORE (V 2.0.0)Holberg Eeg AS20251—
+1K231068autoSCOREHolberg Eeg AS20242—
+1K211452EncevisAustrian Institute of Technology GmbH20213—
+2K260998Ceribell Neurology Review SoftwareCeribell, Inc.20260—
+2K240993encevis (2.1)Ait Austrian Institute of Technology GmbH20242—
+3K261712Ceribell EEG Analysis SoftwareCeribell, Inc.20260—