Not Cleared Direct

DEN220040 - Fibresolve (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220040 · Imvaria, Inc. · Radiology device
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Jan 2024
Decision
562d
Days
Class 2
Risk

DEN220040 is an FDA 510(k) submission (not cleared) for the Fibresolve. Classified as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. (product code QWO), Class II - Special Controls.

Submitted by Imvaria, Inc. (Berkley, US). The FDA issued a Not Cleared (DENG) decision on January 12, 2024 after a review of 562 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 562 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Imvaria, Inc. devices

Submission Details

510(k) Number DEN220040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 29, 2022
Decision Date January 12, 2024
Days to Decision 562 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
455d slower than avg
Panel avg: 107d · This submission: 562d
Pathway characteristics

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.