QWO

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

Product code

QWO

Device name

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

Device class

Class 2

21 CFR

21 CFR 892.2085

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-11-07.

3 summaries are archived here for direct download.