AI Diagnostic Software for Suspicious Lesions
Helps characterize a lesion that has already been found, rather than finding it in the first place.
Detection asks where is it. This device type asks what is it.
These products take a lesion that is already on the table and help describe it: how suspicious it looks, which category it falls into, what the features suggest. The clinical question it supports is usually whether to biopsy.
That makes it an unusually consequential piece of software for its size. A recommendation that shifts a borderline case either way affects a real person within days.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- POK
- FDA name for it
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Rule number
- 21 CFR 892.2060
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask how the output maps onto the reporting categories your team already uses. Software that invents its own scale creates work.
- Ask what the biopsy rate did where it has been installed. That is the number your surgeons and your patients feel.
- Ask how disagreement is handled and recorded, because it will happen and someone has to own it.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Koios Medical, Inc. | 4 |
| Brightheart | 3 |
| Sonio | 2 |
| Brainomix Limited | 2 |
| Ischemaview, Inc. | 2 |
| GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 1 |
| Precision Medical Ventures, Inc. Dba Revealdx | 1 |
| Circle Cardiovascular Imaging, Inc. | 1 |
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 |
|---|---|---|---|
| Koios DS (3.8) | Koios Medical, Inc. | July 2, 2026 | K253884 |
| Sonio Suspect | Sonio | June 4, 2026 | K261519 |
| Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | March 27, 2026 | K254161 |
| RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | January 30, 2026 | K251769 |
| Fetal EchoScan (v1.2) | Brightheart | December 8, 2025 | K252294 |
| StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | July 1, 2025 | K250221 |
| Fetal EchoScan (v1.1) | Brightheart | May 2, 2025 | K251071 |
| Sonio Suspect | Sonio | February 21, 2025 | K243614 |
| Brainomix 360 e-ASPECTS | Brainomix Limited | February 14, 2025 | K243294 |
| Koios DS | Koios Medical, Inc. | November 15, 2024 | K242130 |
| Fetal EchoScan | Brightheart | November 14, 2024 | K242342 |
| EchoSolv AS | Echo IQ, Ltd. | October 4, 2024 | K241245 |
| AISAP Cardio V1.0 | Aisap | August 1, 2024 | K234141 |
| CINA-ASPECTS | Avicenna.Ai | March 15, 2024 | K233342 |
| Rapid ASPECTS (v3) | Ischemaview, Inc. | January 19, 2024 | K232156 |
| Brainomix 360 e-ASPECTS | Brainomix Limited | February 23, 2023 | K221564 |
| Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | November 22, 2022 | K221624 |
| Koios DS | Koios Medical, Inc. | December 16, 2021 | K212616 |
| Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum, Ltd. | March 5, 2021 | K202300 |
| EchoGo Pro | Ultromics, Ltd. | December 18, 2020 | K201555 |
| Rapid ASPECTS | Ischemaview, Inc. | June 26, 2020 | K200760 |
| Koios DS for Breast | Koios Medical, Inc. | July 3, 2019 | K190442 |
| QuantX | Quantitative Insights, Inc. | July 19, 2017 | DEN170022 |
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.