Cleared Traditional

K252041 - Fibresolve (with PCCP) (FDA 510(k) Clearance)

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

K252041 · Imvaria, Inc. · Radiology device
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Nov 2025
Decision
130d
Days
Class 2
Risk

K252041 is an FDA 510(k) clearance for the Fibresolve (with PCCP). Classified as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. (product code QWO), Class II - Special Controls.

Submitted by Imvaria, Inc. (Berkeley, US). The FDA issued a Cleared decision on November 7, 2025 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2085 - 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 Imvaria, Inc. devices

Submission Details

510(k) Number K252041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2025
Decision Date November 07, 2025
Days to Decision 130 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 107d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2085
Definition Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease Is A Prescription Image Processing Device That Analyzes Computed Tomography Images To Suggest The Presence Of Disease Or Of An Imaging Finding Suggestive Of Disease. The Output Of This Device Is Intended To Be Used As Adjunctive Information As Part Of A Referral Pathway In The Overall Diagnostic Assessment Process.
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

RQM+
Dulciana Chan

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.