FDA Clears RevealDx AI Software That Scores Incidental Lung Nodules on CT
RevealAI-Lung gives radiologists a 0-to-1 malignancy similarity score for nodules found by chance on chest CT; it is not cleared for lung cancer screening.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- FDA records list RevealAI-Lung as 510(k) K251769, found substantially equivalent on January 30, 2026; Seattle-based RevealDx announced the clearance on February 3.
- The software compares a radiologist-selected nodule with cases from the National Lung Screening Trial and returns a malignancy similarity index; it is indicated for incidental nodules of 6 to 15 mm in adults.
- RevealDx said the product is now reimbursable under Category III codes 0721T and 0722T and that it expects its first U.S. sites to go live in the first quarter.
The U.S. Food and Drug Administration has cleared RevealAI-Lung, AI software from Seattle-based RevealDx that scores lung nodules found incidentally on chest CT scans for their similarity to known cancers, the company announced on February 3, as reported by Imaging Technology News.
The FDA's 510(k) database lists RevealAI-Lung as K251769, a traditional 510(k) received on June 10, 2025 and found substantially equivalent on January 30, 2026. The applicant is Precision Medical Ventures, Inc., which does business as RevealDx. The device is classified as computer-assisted diagnostic software for lesions suspicious for cancer, product code POK.
What the software does
According to the clearance letter and 510(k) summary, the radiologist identifies a nodule while scrolling through the CT images as usual, and the software compares that nodule's features with a reference database built from National Lung Screening Trial cases with confirmed diagnoses. It returns a malignancy similarity index, or mSI, from 0 to 1, along with a histogram showing how many benign and malignant reference cases fell at that score.
The cleared indication is narrow. The mSI is indicated for incidentally detected nodules 6 to 15 mm in diameter in patients aged 18 or older, and the summary states that it is a relative risk score, not a percentage cancer risk. The document says the mSI is not indicated for lung cancer screening, is not for unassisted reads, and should not be used on CT images acquired at slice spacing above 5 mm.
The predicate device named in the summary is Optellum Software, cleared under K202300. Both products use an AI algorithm to turn imaging features of a confirmed nodule into a single score compared against a database of known cases, the summary says.
Validation and payment claims
RevealDx said it has validated the software on more than 1,500 patients from a variety of cohorts. The company also said that with the clearance, RevealAI-Lung is reimbursable using Category III codes 0721T and 0722T, and that it can be bought directly or through its U.S. distributor, Sirona. It has previously announced integrations with Riverain, a nodule detection company, and with Fuji PACS, ITN reported.
“We are excited to announce that RevealAI-Lung will now be available in the U.S.,” said Chris Wood, chief executive of RevealDx, adding that the company expects “our first sites to go live with the software in the first quarter.”
The company said it had received MDR certification in Europe in November 2025. Its cleared U.S. labeling limits use to radiologists in hospitals and provider offices, with the software's output reviewed alongside other clinical information.
Sources
- 510(k) Premarket Notification K251769: RevealAI-Lung (page as updated 11/02/2026; facts cited were in the January 30, 2026 decision record), U.S. Food and Drug Administration, January 30, 2026
- K251769 clearance letter and 510(k) summary, RevealAI-Lung, U.S. Food and Drug Administration, January 30, 2026
- RevealDx Gets FDA Clearance for RevealAI-Lung, Imaging Technology News, February 4, 2026