510(k) Report

Devices descending from K192320

9 later devices reach HealthCXR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222076EFAI ChestSuite XR Pleural Effusion Assessment SystemEver Fortune.Ai, Co., Ltd.20220—
+1K211733Lunit INSIGHT CXR TriageLunit, Inc.20217—
+2K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+2K243808Rayvolve PTX-PEAZmed20250—
+2K232410SmartChestMilvue20240—
+2K231871Radify TriageEnvisionit Deepai, Ltd.20240—
+2K223754BraveCXBering, Ltd.20230—
+2K230899qXR-PTX-PEQure.Ai Technologies20231—
+3K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc.20240—