510(k) Report

Devices descending from K201555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+1K242342Fetal EchoScanBrightheart20242—
+1K241245EchoSolv ASEcho IQ, Ltd.20240—
+1K234141AISAP Cardio V1.0Aisap20240—
+2K252294Fetal EchoScan (v1.2)Brightheart20250—
+2K251071Fetal EchoScan (v1.1)Brightheart20251—