Devices · Imvaria, Inc.

Fibresolve (with PCCP)

Imvaria, Inc. is listed for Fibresolve (with PCCP) (K252041). The FDA list gives November 7, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QWO as “Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252041

Official FDA database record

Date of final decision

November 7, 2025

Company on the FDA list

Imvaria, Inc.

Lead panel

Radiology

Primary product code

QWO

openFDA device name for the code

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Device class

2

Regulation number

892.2085

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary