Radiology

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
The FDA's own wording: 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 .

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

Companies with the most clearances under AI Triage and Notification Software for Radiology
CompanyCleared products
Aidoc Medical , Ltd.25
Ischemaview, Inc.7
Ever Fortune.Ai, Co., Ltd.5
Avicenna.Ai5
JLK, Inc.4
Brainomix Limited4
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.

All 87 products cleared under AI Triage and Notification Software for Radiology
ProductCompanyClearedFDA 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.