Transparency Registry · product code QAS
Triage & notification AI: all 87 FDA clearances
Radiological Computer-Assisted Triage And Notification Software. Software that analyzes images and flags time-critical findings — stroke, hemorrhage, embolism — to move a study up the reading queue. This list is generated from openFDA public records and refreshes automatically every week — bookmark it and it stays current.
| Device | Applicant | Decision date |
|---|---|---|
| Rapid Vessel Occlusion (Rapid VO) | iSchemaview | 2026-07-13 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | 2026-06-18 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2026-05-14 |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| JLK-NCCT | JLK, Inc. | 2026-03-24 |
| Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | 2026-03-03 |
| BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | 2026-02-26 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2026-01-27 |
| BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | 2026-01-07 |
| Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | 2025-11-25 |
| a2z-Unified-Triage | A2z Radiology Ai, Inc. | 2025-11-24 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2025-11-06 |
| qER-CTA (v1.0) | Qure.Ai Technologies | 2025-09-08 |
| Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | 2025-09-04 |
| Brainomix 360 Triage Stroke | Brainomix Limited | 2025-08-26 |
| Methinks CTA Stroke | Methinks Software, S.L | 2025-08-20 |
| Rapid CTA 360 | Ischemaview | 2025-07-16 |
| Methinks NCCT Stroke | Methinks Software, S.L | 2025-06-16 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2025-05-30 |
| syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | 2025-04-10 |
| JLK-SDH | JLK, Inc. | 2025-03-03 |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2025-02-14 |
| JLK-ICH | JLK, Inc. | 2025-01-03 |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 |
| NeuroICH | Neurocareai, Inc. | 2024-11-07 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2024-10-18 |
| JBS-LVO | JLK, Inc. | 2024-09-27 |
| uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-24 |
| CINA-CSpine | Avicenna.Ai | 2024-09-12 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2024-07-12 |
| Hyper Insight - ICH | Sk, Inc. | 2024-07-01 |
| Heuron ICH | Heuron Co., Ltd. | 2024-05-15 |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 |
| syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2024-03-22 |
| CINA-iPE | Avicenna.Ai | 2024-03-13 |
| Brainomix 360 Triage Stroke | Brainomix Limited | 2023-11-21 |
| BriefCase-Triage | Aidoc Medical , Ltd. | 2023-10-30 |
| Rapid SDH | Ischemaview, Inc. | 2023-10-25 |
| EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 |
| Brainomix 360 Triage LVO | Brainomix Limited | 2023-09-28 |
| Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty , Ltd. | 2023-08-15 |
| Brainomix 360 Triage ICH | Brainomix Limited | 2023-07-27 |
| Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-04-03 |
| Rapid NCCT Stroke | Ischemaview, Inc. | 2023-03-02 |
| CINA | Avicenna.Ai | 2022-11-22 |
| BriefCase | Aidoc Medical , Ltd. | 2022-11-18 |
| Viz LVO ContaCT | Viz. Ai, Inc. | 2022-10-21 |
| BriefCase | Aidoc Medical , Ltd. | 2022-10-07 |
| BriefCase | Aidoc Medical , Ltd. | 2022-09-28 |
| Rapid ICH | Ischemaview, Inc. | 2022-09-12 |
| BriefCase | Aidoc Medical , Ltd. | 2022-08-26 |
| Viz SDH | Viz. Ai, Inc. | 2022-07-25 |
| BriefCase | Aidoc Medical , Ltd. | 2022-06-03 |
| Rapid LVO | Ischemaview, Inc. | 2022-05-31 |
| BriefCase | Aidoc Medical , Ltd. | 2022-05-17 |
| Rapid PE Triage and Notification (PETN) | Ischemaview, Inc. | 2022-05-17 |
| BriefCase | Aidoc Medical , Ltd. | 2022-04-26 |
| BriefCase | Aidoc Medical , Ltd. | 2022-03-21 |
| syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2022-01-28 |
| StrokeSENS LVO | Circle Neurovascular Imaging, Inc. | 2021-10-14 |
| InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | 2021-08-12 |
| HALO | Nicolab B.V. | 2021-07-08 |
| CINA CHEST | Avicenna.Ai | 2021-05-19 |
| Viz ICH | Viz. Ai, Inc. | 2021-03-23 |
| BriefCase | Aidoc Medical , Ltd. | 2020-12-29 |
| HALO | Nico-Lab B.V. | 2020-11-20 |
| BriefCase | Aidoc Medical , Ltd. | 2020-08-26 |
| Accipiolx | Maxq AL , Ltd. | 2020-08-07 |
| Rapid LVO | Ischemaview, Inc. | 2020-07-09 |
| CINA | Avicenna.Ai | 2020-06-24 |
| BriefCase | Aidoc Medical , Ltd. | 2020-06-19 |
| qER | Qure.Ai Technologies | 2020-06-17 |
| NinesAI | Nines, Inc. | 2020-04-21 |
| CuraRad-ICH | Curacloud Corp. | 2020-04-13 |
| Rapid ICH | Ischemaview Incorporated | 2020-03-31 |
| Viz ICH | Viz. Ai, Inc. | 2020-03-18 |
| BriefCase | Aidoc Medical , Ltd. | 2019-12-20 |
| DeepCT | Deep01 Limited | 2019-07-10 |
| HealthICH | Zebra Medical Vision, Ltd. | 2019-06-13 |
| BriefCase | Aidoc Medical , Ltd. | 2019-05-31 |
| BriefCase | Aidoc Medical , Ltd. | 2019-04-15 |
| Accipiolx | Maxq-Al , Ltd. | 2018-10-26 |
| BriefCase | Aidoc Medical , Ltd. | 2018-08-01 |
| ContaCT | Viz.Al, Inc. | 2018-02-13 |
Facts only, sourced per entry. Listing is not evaluation. Full methodology on the registry index. Evaluating this category? The due-diligence checklist and free instruments are where buyers start.