QAS
87 FDA 510(k) clearances · Product code
104 daysmedian time to decision
224 days90th percentile
87clearances measured
FDA profile
- Official device name
- Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Medical specialty
- Radiology
- FDA definition
- Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Rapid Vessel Occlusion (Rapid VO) (K261085) | iSchemaview | 2026-07-13 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) (K260729) | GuideAI Health | 2026-06-18 |
| BriefCase-Triage (K261317) | Aidoc Medical , Ltd. | 2026-05-14 |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) (K253163) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| JLK-NCCT (K252421) | JLK, Inc. | 2026-03-24 |
| Annalise Enterprise (K253818) | 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 (K253578) | Aidoc Medical , Ltd. | 2026-02-26 |
| BriefCase-Triage (K251195) | Aidoc Medical , Ltd. | 2026-01-27 |
| BriefCase-Triage: CARE Multi-triage CT Body (K252970) | Aidoc Medical , Ltd. | 2026-01-07 |
| Scaida BrainCT-ICH (v1.0) (K250694) | Mlhealth 360 | 2025-11-25 |
| a2z-Unified-Triage (K252366) | A2z Radiology Ai, Inc. | 2025-11-24 |
| BriefCase-Triage (K253265) | Aidoc Medical , Ltd. | 2025-11-06 |
| qER-CTA (v1.0) (K251610) | Qure.Ai Technologies | 2025-09-08 |
| Rapid Obstructive Hydrocephalus, Rapid OH (K251533) | Ischemaview, Inc. | 2025-09-04 |
| Brainomix 360 Triage Stroke (K251983) | Brainomix Limited | 2025-08-26 |
| Methinks CTA Stroke (K251590) | Methinks Software, S.L | 2025-08-20 |
| Rapid CTA 360 (K251151) | Ischemaview | 2025-07-16 |
| Methinks NCCT Stroke (K250685) | Methinks Software, S.L | 2025-06-16 |
| BriefCase-Triage (K251406) | Aidoc Medical , Ltd. | 2025-05-30 |
| syngo.CT LVO Detection (K243145) | Siemens Medical Solutions USA, Inc. | 2025-04-10 |
| JLK-SDH (K243611) | JLK, Inc. | 2025-03-03 |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (K242821) | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 |
| BriefCase-Triage (K250248) | Aidoc Medical , Ltd. | 2025-02-14 |
| JLK-ICH (K243363) | JLK, Inc. | 2025-01-03 |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (K241923) | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 |
| NeuroICH (K241719) | Neurocareai, Inc. | 2024-11-07 |
| BriefCase-Triage (K242837) | Aidoc Medical , Ltd. | 2024-10-18 |
| JBS-LVO (K241480) | JLK, Inc. | 2024-09-27 |
| uAI Easy Triage ICH (K242292) | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-24 |
| CINA-CSpine (K240942) | Avicenna.Ai | 2024-09-12 |
| BriefCase-Triage (K241727) | Aidoc Medical , Ltd. | 2024-07-12 |
| Hyper Insight - ICH (K240353) | Sk, Inc. | 2024-07-01 |
| Heuron ICH (K233247) | Heuron Co., Ltd. | 2024-05-15 |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (K240291) | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 |
| syngo.CT Brain Hemorrhage (K232431) | Siemens Medical Solutions USA, Inc. | 2024-03-22 |
| CINA-iPE (K233968) | Avicenna.Ai | 2024-03-13 |
| Brainomix 360 Triage Stroke (K232496) | Brainomix Limited | 2023-11-21 |
| BriefCase-Triage (K232751) | Aidoc Medical , Ltd. | 2023-10-30 |
| Rapid SDH (K232436) | Ischemaview, Inc. | 2023-10-25 |
| EFAI NeuroSuite CT ICH Assessment System (K231025) | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 |
| Brainomix 360 Triage LVO (K231837) | Brainomix Limited | 2023-09-28 |
| Annalise Enterprise CTB Triage Trauma (K231767) | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| Annalise Enterprise CTB Triage Trauma (K231384) | Annalise-Ai Pty , Ltd. | 2023-09-22 |
| Annalise Enterprise CTB Triage-OH (K231094) | Annalise-Ai Pty , Ltd. | 2023-08-15 |
| Brainomix 360 Triage ICH (K231195) | Brainomix Limited | 2023-07-27 |
| Annalise Enterprise CTB Triage Trauma (K223240) | Annalise-Ai Pty , Ltd. | 2023-04-03 |
| Rapid NCCT Stroke (K222884) | Ischemaview, Inc. | 2023-03-02 |
| CINA (K221716) | Avicenna.Ai | 2022-11-22 |
| BriefCase (K221330) | Aidoc Medical , Ltd. | 2022-11-18 |
| Viz LVO ContaCT (K223042) | Viz. Ai, Inc. | 2022-10-21 |
| BriefCase (K220709) | Aidoc Medical , Ltd. | 2022-10-07 |
| BriefCase (K222329) | Aidoc Medical , Ltd. | 2022-09-28 |
| Rapid ICH (K221456) | Ischemaview, Inc. | 2022-09-12 |
| BriefCase (K222277) | Aidoc Medical , Ltd. | 2022-08-26 |
| Viz SDH (K220439) | Viz. Ai, Inc. | 2022-07-25 |
| BriefCase (K221314) | Aidoc Medical , Ltd. | 2022-06-03 |
| Rapid LVO (K221248) | Ischemaview, Inc. | 2022-05-31 |
| BriefCase (K221240) | Aidoc Medical , Ltd. | 2022-05-17 |
| Rapid PE Triage and Notification (PETN) (K220499) | Ischemaview, Inc. | 2022-05-17 |
| BriefCase (K213886) | Aidoc Medical , Ltd. | 2022-04-26 |
| BriefCase (K213721) | Aidoc Medical , Ltd. | 2022-03-21 |
| syngo.CT Brain Hemorrhage (K203260) | Siemens Medical Solutions USA, Inc. | 2022-01-28 |
| StrokeSENS LVO (K212261) | Circle Neurovascular Imaging, Inc. | 2021-10-14 |
| InferRead CT Stroke.AI (K211179) | Infervision Medical Technology Co., Ltd. | 2021-08-12 |
| HALO (K211788) | Nicolab B.V. | 2021-07-08 |
| CINA CHEST (K210237) | Avicenna.Ai | 2021-05-19 |
| Viz ICH (K210209) | Viz. Ai, Inc. | 2021-03-23 |
| BriefCase (K203508) | Aidoc Medical , Ltd. | 2020-12-29 |
| HALO (K200873) | Nico-Lab B.V. | 2020-11-20 |
| BriefCase (K201020) | Aidoc Medical , Ltd. | 2020-08-26 |
| Accipiolx (K201310) | Maxq AL , Ltd. | 2020-08-07 |
| Rapid LVO (K200941) | Ischemaview, Inc. | 2020-07-09 |
| CINA (K200855) | Avicenna.Ai | 2020-06-24 |
| BriefCase (K193298) | Aidoc Medical , Ltd. | 2020-06-19 |
| qER (K200921) | Qure.Ai Technologies | 2020-06-17 |
| NinesAI (K193351) | Nines, Inc. | 2020-04-21 |
| CuraRad-ICH (K192167) | Curacloud Corp. | 2020-04-13 |
| Rapid ICH (K193087) | Ischemaview Incorporated | 2020-03-31 |
| Viz ICH (K193658) | Viz. Ai, Inc. | 2020-03-18 |
| BriefCase (K192383) | Aidoc Medical , Ltd. | 2019-12-20 |
| DeepCT (K182875) | Deep01 Limited | 2019-07-10 |
| HealthICH (K190424) | Zebra Medical Vision, Ltd. | 2019-06-13 |
| BriefCase (K190896) | Aidoc Medical , Ltd. | 2019-05-31 |
| BriefCase (K190072) | Aidoc Medical , Ltd. | 2019-04-15 |
| Accipiolx (K182177) | Maxq-Al , Ltd. | 2018-10-26 |
| BriefCase (K180647) | Aidoc Medical , Ltd. | 2018-08-01 |
| ContaCT (DEN170073) | Viz.Al, Inc. | 2018-02-13 |
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