# K242467: IQ-UIP

- Pathway: 510(k) (Traditional)
- Applicant: Imbio, Inc.
- Decided: Dec 19, 2024 after 121 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 6.

## Indications for use
Imbio IQ-UIP is a computer-aided software indicated for use in passively notifying specialists associated with interstitial lung disease (ILD) centers of radiological findings suggestive of radiological usual interstitial pneumonia (UIP) in non-contrast, chest CT scans of adults. Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. Identification of positive findings include summary reports with a clinical guideline reference for the definition of UIP pattern that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Imbio IQ-UIP are used to notify specialists at an ILD center of radiological findings that may be consistent with UIP. These specialists are qualified clinicians experienced in evaluating chest CTs for ILD. Input images originate from within the same hospital network associated with the ILD center. The results of Imbio IQ-UIP are intended to be used in conjunction with additional patient information and based on the user's professional judgment, to assist with the review of medical images. Notified clinicians are responsible for viewing full image series and making final clinical determinations.

Source page: https://510kreport.com/device/K242467
Methodology: https://510kreport.com/methodology