510(k) Report

Devices descending from K003230

2 later devices reach V Score with Auto Gate Model TBD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243240Vitrea CT VScoreCanon Medical Informatics, Inc.20250—
+1K012106Accuimage Smartgate UpgradeAccuimage Diagnostics Corp.20010—