RevealAI-Lung

FDA 510(k) K251769 · Precision Medical Ventures, Inc. Dba Revealdx

Substantially Equivalent

510(k) numberK251769

Submission

Device name
RevealAI-Lung
Applicant
Precision Medical Ventures, Inc. Dba Revealdx
Seattle, WA, US
Received
June 10, 2025
Decision date
January 30, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2060
Specialty
Radiology

Assist users in characterizing lesions identified on acquired medical images

Other 510(k)s with product code POK

510(k)DeviceApplicantDecision
K253884Koios DS (3.8)POK · Traditional Koios Medical, Inc.07/02/2026SE
K261519Sonio SuspectPOK · Special Sonio06/04/2026SE
K254161Automated Aortic Stenosis Software (AutoAS)POK · Traditional GE Medical Systems Ultrasound & Primary Care…03/27/2026SE
K252294Fetal EchoScan (v1.2)POK · Traditional Brightheart12/08/2025SE
K250221StrokeSENS ASPECTS Software ApplicationPOK · Traditional Circle Cardiovascular Imaging, Inc.07/01/2025SE
K251071Fetal EchoScan (v1.1)POK · Special Brightheart05/02/2025SE
K243614Sonio SuspectPOK · Traditional Sonio02/21/2025SE
K243294Brainomix 360 e-ASPECTSPOK · Traditional Brainomix Limited02/14/2025SE
K242130Koios DSPOK · Traditional Koios Medical, Inc.11/15/2024SE
K242342Fetal EchoScanPOK · Traditional Brightheart11/14/2024SE

Questions and answers

When was RevealAI-Lung cleared by the FDA?

RevealAI-Lung (K251769) received a 510(k) decision of Substantially Equivalent on January 30, 2026, 234 days after the submission was received.

What is the product code of K251769?

The FDA product code is POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2060.