510(k) Report

Devices descending from K213544

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2503303mensio WorkstationPie Medical Imaging BV202501
+1K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+1K230209Sonix HealthOntact Health Co., Ltd.20233—
+2K243684BrightHeart View ClassifierBrightheart20251—
+2K240645Sonix HealthOntact Health Co., Ltd.20240—
+3K251456BrightHeart View ClassifierBrightheart20250—