510(k) K241891

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 10, 2025

Date Received

June 28, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

892.2085

Review Panel

RA

Submission Type

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.