510(k) Report

Devices descending from K201632

10 later devices reach Tomtec-Arena through their predicates, nearest generation first.

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