510(k) Report

Devices descending from K190362

23 later devices reach HealthPNX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221868QOCA image Smart CXR Image Processing SystemQuanta Computer, Inc.20230—
+1K221241DrAid for Radiology v1Vinbrain Joint Stock Company20220—
+1K193300AIMI-Triage CXR PTXRadlogics, Inc.20202—
+1K191556Red DotBehold.Ai Technologies Limited20206—
+1K192320HealthCXRZebra Medical Vision, Ltd.20199—
+1K183182Critical Care SuiteGe Medical Systems, LLC20198—
+2K221552EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune.Ai, Co., Ltd.20220—
+2K222076EFAI ChestSuite XR Pleural Effusion Assessment SystemEver Fortune.Ai, Co., Ltd.20220—
+2K214043BriefCaseAidoc Medical, Ltd.20220—
+2K213566ClearRead Xray PneumothoraxRiverain Technologies, Inc.20220—
+2K213941Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai20223—
+2K211803HealthPPTZebra Medical Vision, Ltd.20210—
+2K211733Lunit INSIGHT CXR TriageLunit, Inc.20217—
+3K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+3K243808Rayvolve PTX-PEAZmed20250—
+3K232410SmartChestMilvue20240—
+3K231871Radify TriageEnvisionit Deepai, Ltd.20240—
+3K223754BraveCXBering, Ltd.20230—
+3K230899qXR-PTX-PEQure.Ai Technologies20231—
+3K222179Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd.20231—
+3K222268Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+4K250831Annalise EnterpriseAnnalise-Ai20250—
+4K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc.20240—