AI Triage and Notification Software for Radiology
Moves a scan that may show something urgent to the front of the reading queue. It is not allowed to say what it found.
This is the single largest group of cleared AI in American healthcare, and the most commonly misunderstood.
Picture a hospital reading list as a stack of paper in the order it arrived. These products read the stack and move likely emergencies to the top. That is the whole job. A bleed in the brain, a blocked lung artery, a collapsed lung: the software recognizes a pattern and pushes that case up.
Here is the part that surprises people. Under this device type the software is not permitted to tell the radiologist what it thinks it saw. It may only say this one should be looked at sooner. The diagnosis stays entirely with the doctor, who reads the scan the same way they always would.
That limit is deliberate, and it is why so many products land here. Speeding up a queue is a lower risk claim than making a call, so it is an easier door to get through. When a vendor demo shows a confident red box over a bleed, ask which device type that screen was cleared under.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QAS
- FDA name for it
- Radiological Computer-Assisted Triage And Notification Software
- Rule number
- 21 CFR 892.2080
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask what happens to the cases it does not flag. A triage tool that misses something has not made a wrong diagnosis. It has quietly left a case in normal order, and your workflow needs to assume that.
- Ask for the turnaround improvement measured at a hospital your size, not the model accuracy number. Time saved is the claim this device type actually makes.
- Ask how it connects to the worklist you already use. Most of the failed installs are integration problems, not model problems.
- Ask what happens when the software is down. If the queue silently returns to arrival order and nobody is told, that is a safety issue rather than an IT issue.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Aidoc Medical , Ltd. | 25 |
| Ischemaview, Inc. | 7 |
| Ever Fortune.Ai, Co., Ltd. | 5 |
| Avicenna.Ai | 5 |
| JLK, Inc. | 4 |
| Brainomix Limited | 4 |
| Annalise-Ai Pty , Ltd. | 4 |
| Viz. Ai, Inc. | 4 |
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Rapid Vessel Occlusion (Rapid VO) | iSchemaview | July 13, 2026 | K261085 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | June 18, 2026 | K260729 |
| BriefCase-Triage | Aidoc Medical , Ltd. | May 14, 2026 | K261317 |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | April 22, 2026 | K253163 |
| JLK-NCCT | JLK, Inc. | March 24, 2026 | K252421 |
| Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | March 3, 2026 | K253818 |
| BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | February 26, 2026 | K253578 |
| BriefCase-Triage | Aidoc Medical , Ltd. | January 27, 2026 | K251195 |
| BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | January 7, 2026 | K252970 |
| Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | November 25, 2025 | K250694 |
| a2z-Unified-Triage | A2z Radiology Ai, Inc. | November 24, 2025 | K252366 |
| BriefCase-Triage | Aidoc Medical , Ltd. | November 6, 2025 | K253265 |
| qER-CTA (v1.0) | Qure.Ai Technologies | September 8, 2025 | K251610 |
| Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | September 4, 2025 | K251533 |
| Brainomix 360 Triage Stroke | Brainomix Limited | August 26, 2025 | K251983 |
| Methinks CTA Stroke | Methinks Software, S.L | August 20, 2025 | K251590 |
| Rapid CTA 360 | Ischemaview | July 16, 2025 | K251151 |
| Methinks NCCT Stroke | Methinks Software, S.L | June 16, 2025 | K250685 |
| BriefCase-Triage | Aidoc Medical , Ltd. | May 30, 2025 | K251406 |
| syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | April 10, 2025 | K243145 |
| JLK-SDH | JLK, Inc. | March 3, 2025 | K243611 |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. | February 20, 2025 | K242821 |
| BriefCase-Triage | Aidoc Medical , Ltd. | February 14, 2025 | K250248 |
| JLK-ICH | JLK, Inc. | January 3, 2025 | K243363 |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.Ai, Co., Ltd. | December 6, 2024 | K241923 |
| NeuroICH | Neurocareai, Inc. | November 7, 2024 | K241719 |
| BriefCase-Triage | Aidoc Medical , Ltd. | October 18, 2024 | K242837 |
| JBS-LVO | JLK, Inc. | September 27, 2024 | K241480 |
| uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | September 24, 2024 | K242292 |
| CINA-CSpine | Avicenna.Ai | September 12, 2024 | K240942 |
| BriefCase-Triage | Aidoc Medical , Ltd. | July 12, 2024 | K241727 |
| Hyper Insight - ICH | Sk, Inc. | July 1, 2024 | K240353 |
| Heuron ICH | Heuron Co., Ltd. | May 15, 2024 | K233247 |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. | April 8, 2024 | K240291 |
| syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | March 22, 2024 | K232431 |
| CINA-iPE | Avicenna.Ai | March 13, 2024 | K233968 |
| Brainomix 360 Triage Stroke | Brainomix Limited | November 21, 2023 | K232496 |
| BriefCase-Triage | Aidoc Medical , Ltd. | October 30, 2023 | K232751 |
| Rapid SDH | Ischemaview, Inc. | October 25, 2023 | K232436 |
| EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | October 4, 2023 | K231025 |
| Brainomix 360 Triage LVO | Brainomix Limited | September 28, 2023 | K231837 |
| Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | September 22, 2023 | K231384 |
| Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | September 22, 2023 | K231767 |
| Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty , Ltd. | August 15, 2023 | K231094 |
| Brainomix 360 Triage ICH | Brainomix Limited | July 27, 2023 | K231195 |
| Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | April 3, 2023 | K223240 |
| Rapid NCCT Stroke | Ischemaview, Inc. | March 2, 2023 | K222884 |
| CINA | Avicenna.Ai | November 22, 2022 | K221716 |
| BriefCase | Aidoc Medical , Ltd. | November 18, 2022 | K221330 |
| Viz LVO ContaCT | Viz. Ai, Inc. | October 21, 2022 | K223042 |
| BriefCase | Aidoc Medical , Ltd. | October 7, 2022 | K220709 |
| BriefCase | Aidoc Medical , Ltd. | September 28, 2022 | K222329 |
| Rapid ICH | Ischemaview, Inc. | September 12, 2022 | K221456 |
| BriefCase | Aidoc Medical , Ltd. | August 26, 2022 | K222277 |
| Viz SDH | Viz. Ai, Inc. | July 25, 2022 | K220439 |
| BriefCase | Aidoc Medical , Ltd. | June 3, 2022 | K221314 |
| Rapid LVO | Ischemaview, Inc. | May 31, 2022 | K221248 |
| Rapid PE Triage and Notification (PETN) | Ischemaview, Inc. | May 17, 2022 | K220499 |
| BriefCase | Aidoc Medical , Ltd. | May 17, 2022 | K221240 |
| BriefCase | Aidoc Medical , Ltd. | April 26, 2022 | K213886 |
| BriefCase | Aidoc Medical , Ltd. | March 21, 2022 | K213721 |
| syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | January 28, 2022 | K203260 |
| StrokeSENS LVO | Circle Neurovascular Imaging, Inc. | October 14, 2021 | K212261 |
| InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | August 12, 2021 | K211179 |
| HALO | Nicolab B.V. | July 8, 2021 | K211788 |
| CINA CHEST | Avicenna.Ai | May 19, 2021 | K210237 |
| Viz ICH | Viz. Ai, Inc. | March 23, 2021 | K210209 |
| BriefCase | Aidoc Medical , Ltd. | December 29, 2020 | K203508 |
| HALO | Nico-Lab B.V. | November 20, 2020 | K200873 |
| BriefCase | Aidoc Medical , Ltd. | August 26, 2020 | K201020 |
| Accipiolx | Maxq AL , Ltd. | August 7, 2020 | K201310 |
| Rapid LVO | Ischemaview, Inc. | July 9, 2020 | K200941 |
| CINA | Avicenna.Ai | June 24, 2020 | K200855 |
| BriefCase | Aidoc Medical , Ltd. | June 19, 2020 | K193298 |
| qER | Qure.Ai Technologies | June 17, 2020 | K200921 |
| NinesAI | Nines, Inc. | April 21, 2020 | K193351 |
| CuraRad-ICH | Curacloud Corp. | April 13, 2020 | K192167 |
| Rapid ICH | Ischemaview Incorporated | March 31, 2020 | K193087 |
| Viz ICH | Viz. Ai, Inc. | March 18, 2020 | K193658 |
| BriefCase | Aidoc Medical , Ltd. | December 20, 2019 | K192383 |
| DeepCT | Deep01 Limited | July 10, 2019 | K182875 |
| HealthICH | Zebra Medical Vision, Ltd. | June 13, 2019 | K190424 |
| BriefCase | Aidoc Medical , Ltd. | May 31, 2019 | K190896 |
| BriefCase | Aidoc Medical , Ltd. | April 15, 2019 | K190072 |
| Accipiolx | Maxq-Al , Ltd. | October 26, 2018 | K182177 |
| BriefCase | Aidoc Medical , Ltd. | August 1, 2018 | K180647 |
| ContaCT | Viz.Al, Inc. | February 13, 2018 | DEN170073 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.