# DEN220040: Fibresolve

- Pathway: De Novo (Direct)
- Applicant: Imvaria, Inc.
- Decided: Jan 12, 2024 after 562 days
- Product code: QWO (Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.)
- Device class: 2
- Regulation: 21 CFR 892.2085
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252041: Fibresolve (with PCCP) (2025), 0 descendants of its own
- K241891: ScreenDx (2025), 0 descendants of its own
- K242467: IQ-UIP (2024), 0 descendants of its own

## Indications for use
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. The results of Fibresolve are intended to be used only by clinicians qualified in the care of lung disease, specifically in caring for patients with ILD, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment. The input to Fibresolve is a DICOM‐compliant lung CT scan. Clinical case eligibility includes the following criteria: Age > 22 years old. Pulmonary symptoms suggestive of possible ILD including IPF.

Source page: https://510kreport.com/device/DEN220040
Methodology: https://510kreport.com/methodology