AI Lesion Prioritization Software for Radiology
Sorts studies by how likely they are to contain a lesion, so the most suspicious ones get read first.
Close cousin to triage software, with a narrower target. Instead of watching for a time-critical emergency, these products rank studies by how likely they are to contain a lesion worth a closer look.
The value is in the order of the queue, not in the answer. On a list of two hundred screening studies, reading the twenty most suspicious first changes how long a worrying finding sits unread.
As with triage, the software may sort but it may not conclude. The radiologist still reads every study.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QFM
- FDA name for it
- Radiological Computer-Assisted Prioritization Software For Lesions
- Rule number
- 21 CFR 892.2080
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask what happens to the bottom of the sorted list on a busy day. Reordering only helps if everything still gets read.
- Ask which population the ranking was tuned on. A model trained on one screening program can rank very differently on another.
- Ask whether the ranking is visible to the reader. Knowing the software thought a study was suspicious can nudge a reading, which is worth deciding on deliberately.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Aidoc Medical , Ltd. | 5 |
| Zebra Medical Vision, Ltd. | 5 |
| Neurocareai, Inc. (Dba Savelife.Ai) | 2 |
| Medcognetics, Inc. | 2 |
| Annalise-Ai | 2 |
| Annalise-Ai Pty , Ltd. | 2 |
| Viz. Ai, Inc. | 2 |
| Ever Fortune.Ai, Co., Ltd. | 2 |
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 |
|---|---|---|---|
| CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | July 8, 2026 | K253751 |
| MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | May 4, 2026 | K252954 |
| CogNet AI-MT+ | Medcognetics, Inc. | December 11, 2025 | K252482 |
| Annalise Enterprise | Annalise-Ai | April 23, 2025 | K250831 |
| Rayvolve PTX-PE | AZmed | March 21, 2025 | K243808 |
| BriefCase-Triage | Aidoc Medical , Ltd. | December 11, 2024 | K243548 |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | November 15, 2024 | K241439 |
| CINA-VCF | Avicenna.Ai | May 31, 2024 | K240612 |
| VinDr-Mammo | Vinbigdata Joint Stock Company | May 23, 2024 | K233108 |
| SmartChest | Milvue | May 10, 2024 | K232410 |
| Radify Triage | Envisionit Deepai, Ltd. | January 17, 2024 | K231871 |
| BraveCX | Bering, Ltd. | November 9, 2023 | K223754 |
| qXR-PTX-PE | Qure.Ai Technologies | August 22, 2023 | K230899 |
| Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | July 27, 2023 | K230074 |
| Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | March 28, 2023 | K222268 |
| Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | March 28, 2023 | K222179 |
| Viz AAA | Viz. Ai, Inc. | March 17, 2023 | K223443 |
| BriefCase | Aidoc Medical , Ltd. | February 1, 2023 | K230020 |
| QOCA image Smart CXR Image Processing System | Quanta Computer, Inc. | January 27, 2023 | K221868 |
| BriefCase | Aidoc Medical , Ltd. | December 5, 2022 | K222692 |
| EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | November 8, 2022 | K221552 |
| CogNet QmTRIAGE | Medcognetics, Inc. | September 29, 2022 | K220080 |
| EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.Ai, Co., Ltd. | September 8, 2022 | K222076 |
| DrAid for Radiology v1 | Vinbrain Joint Stock Company | September 1, 2022 | K221241 |
| BriefCase | Aidoc Medical , Ltd. | March 14, 2022 | K214043 |
| ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | March 10, 2022 | K213566 |
| Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | February 24, 2022 | K213941 |
| Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | February 18, 2022 | K213319 |
| HealthPPT | Zebra Medical Vision, Ltd. | December 15, 2021 | K211803 |
| Lunit INSIGHT CXR Triage | Lunit, Inc. | November 10, 2021 | K211733 |
| Saige-Q | DeepHealth, Inc. | April 16, 2021 | K203517 |
| BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical , Ltd. | April 14, 2021 | K202992 |
| uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | January 15, 2021 | K193271 |
| HealthMammo | Zebra Medical Vision, Ltd. | July 16, 2020 | K200905 |
| HealthVCF | Zebra Medical Vision, Ltd. | May 12, 2020 | K192901 |
| AIMI-Triage CXR PTX | Radlogics, Inc. | April 8, 2020 | K193300 |
| Red Dot | Behold.Ai Technologies Limited | February 28, 2020 | K191556 |
| HealthCXR | Zebra Medical Vision, Ltd. | November 26, 2019 | K192320 |
| Critical Care Suite | Ge Medical Systems, LLC | August 12, 2019 | K183182 |
| HealthPNX | Zebra Medical Vision, Ltd. | May 6, 2019 | K190362 |
| cmTriage | Curemetrix, Inc. | March 8, 2019 | K183285 |
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.