21 CFR 892.2085 — Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.2085
Identification
Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the standard-of-care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate Multidisciplinary Discussion (MDD) or as part of an MDD. Specifically, the tool is used to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QWO | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | 2 | 4 | SaMD |
Special Controls
QWO — Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
In combination with the general controls of the FD&C Act, radiology software for referral of findings related to fibrotic lung disease is subject to the following special controls:
De Novo Order DEN220040
