510(k) Report

Devices descending from DEN200069

5 later devices reach Cognoa ASD Diagnosis Aid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243558Canvas DxCognoa, Inc.20250—
+1K213882EarliPoint SystemEarlitec Diagnostics, Inc.20223—
+2K230337EarliPointEarlitec Diagnostics, Inc.20232—
+3K243891EarliPoint SystemEarlitec Diagnostics20251—
+4K253442EarliPoint AssessmentEarlitec Diagnostics20260—