Product code QWO

Device name

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

Medical specialty

Radiology

Device class

2

Regulation number

892.2085

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset