# K251769: RevealAI-Lung

- Pathway: 510(k) (Traditional)
- Applicant: Precision Medical Ventures, Inc. Dba Revealdx
- Decided: Jan 30, 2026 after 234 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170022 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202300: Optellum Virtual Nodule Clinic, Optellum software, Optellum platform, Optellum, Ltd. (2021) Summary page 5.

## Indications for use
RevealAI-Lung Software is a computer aided diagnostic (CADx) software application intended for the characterization of incidentally-detected lung nodules on computed tomography (CT) scans. When a nodule is identified, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians’ assessment of patients’ cancer risk. The mSI score is indicated for the evaluation of incidentally-detected pulmonary nodules of diameter 6-15mm in patients aged 18 years or above. In cases where multiple abnormalities are present, the mSI score can be used to assess each abnormality independently. Risk should be interpreted on an individual patient level and mSI is a relative risk score, not a percentage cancer risk. Note that mSI is not indicated for lung cancer screening. The validation data excluded CT images with missing slices.

Source page: https://510kreport.com/device/K251769
Methodology: https://510kreport.com/methodology