# K241891: ScreenDx

- Pathway: 510(k) (Traditional)
- Applicant: Imvaria, Inc.
- Decided: Jan 10, 2025 after 196 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
Longest line of descent: 1 generation back to DEN220040 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220040: Fibresolve, Imvaria, Inc. (2024) Summary page 5.

## Indications for use
ScreenDx is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to assess for interstitial lung findings compatible with interstitial lung disease. The device supplements the standard-of-care workflow by providing a qualitative output of imaging findings based on pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriately qualified clinician. Patients with positively identified patterns may undergo assessment for lung fibrosis, but ScreenDx does not replace the current standard of care methods for diagnosis of lung fibrosis and the results of the device are not intended to rule-out or rule-in lung fibrosis. The results of ScreenDx are intended to be used only by clinicians qualified in the care of lung disease, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment. The input to ScreenDx is a DICOM-compliant lung CT scan. Clinical case eligibility includes the following criteria: • Age > 22 years old.

Source page: https://510kreport.com/device/K241891
Methodology: https://510kreport.com/methodology