# K262015: Elucid FFR-IQ (B.1)

- Pathway: 510(k) (Traditional)
- Applicant: Elucid Bioimaging, Inc.
- Decided: Sep 29, 2026 after 106 days
- Product code: PJA (Coronary Vascular Physiologic Simulation Software)
- Device class: 2
- Regulation: 21 CFR 870.1415
- 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 DEN130045 (2014). 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)
- DEN130045: Heartflow Ffrct, Heartflow (2014) Summary page 5.

## Indications for use
Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values computed from coronary CTA images using Al-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease. The FFR-IQ results are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. FFR-IQ results are intended to be used by qualified clinicians in conjunction with the with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional ·udqment.

Source page: https://510kreport.com/device/K262015
Methodology: https://510kreport.com/methodology