510(k) Report

Devices descending from K211733

7 later devices reach Lunit INSIGHT CXR Triage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+1K243808Rayvolve PTX-PEAZmed20250—
+1K232410SmartChestMilvue20240—
+1K231871Radify TriageEnvisionit Deepai, Ltd.20240—
+1K223754BraveCXBering, Ltd.20230—
+1K230899qXR-PTX-PEQure.Ai Technologies20231—
+2K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc.20240—