510(k) Report

Devices descending from K200974

12 later devices reach QLAB Advanced Quantification Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200603AAA ModelPhilips Ultrasound, Inc.20200—
+1K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+2K251417ReVISION 2Argus Cognitive, Inc.20260—
+2K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+2K212376Caas QardiaPie Medical Imaging BV20220—
+2K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+3K2503303mensio WorkstationPie Medical Imaging BV202501
+3K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+3K230209Sonix HealthOntact Health Co., Ltd.20233—
+4K243684BrightHeart View ClassifierBrightheart20251—
+4K240645Sonix HealthOntact Health Co., Ltd.20240—
+5K251456BrightHeart View ClassifierBrightheart20250—