DeviceClearance

Product code QWO— Radiology

Fibresolve

Classification name
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Device class
Class 2
Regulation
21 CFR 892.2085
Advisory panel
Radiology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QWO under 21 CFR 892.2085, via openFDA

Market context for product code QWO

FDA has cleared 4 devices under product code QWO between 2024 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QWO

Recent clearances under product code QWO

Data sourced from openFDA. This site is unofficial and independent of the FDA.