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

QWO · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2085

Classification

FDA Product Code: QWO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.2085
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown