Cleared Traditional

K251769 - RevealAI-Lung (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251769 · Precision Medical Ventures, Inc. Dba Revealdx · Radiology device
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Jan 2026
Decision
234d
Days
Class 2
Risk

K251769 is an FDA 510(k) clearance for the RevealAI-Lung. Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Precision Medical Ventures, Inc. Dba Revealdx (Seattle, US). The FDA issued a Cleared decision on January 30, 2026 after a review of 234 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Medical Ventures, Inc. Dba Revealdx devices

Submission Details

510(k) Number K251769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2025
Decision Date January 30, 2026
Days to Decision 234 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 107d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US Lpp
Michael Calhoun

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

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