510(k) Report

Devices descending from K161959

13 later devices reach ClearView cCAD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190442Koios DS for BreastKoios Medical, Inc.201912—
+2K212616Koios DSKoios Medical, Inc.20214—
+2K201555EchoGo ProUltromics, Ltd.20206—
+3K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+3K243614Sonio SuspectSonio20251—
+3K242130Koios DSKoios Medical, Inc.20241—
+3K242342Fetal EchoScanBrightheart20242—
+3K241245EchoSolv ASEcho IQ, Ltd.20240—
+3K234141AISAP Cardio V1.0Aisap20240—
+4K253884Koios DS (3.8)Koios Medical, Inc.20260—
+4K261519Sonio SuspectSonio20260—
+4K252294Fetal EchoScan (v1.2)Brightheart20250—
+4K251071Fetal EchoScan (v1.1)Brightheart20251—