510(k) Report

Devices descending from K190442

12 later devices reach Koios DS for Breast through their predicates, nearest generation first.

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