Devices · Imvaria, Inc

Fibresolve

Imvaria, Inc is listed for Fibresolve (DEN220040). The FDA list gives January 12, 2024 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo 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 “Unknown.” 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/denovo.cfm?id=DEN220040

Official FDA database record

Date of final decision

January 12, 2024

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

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned