# K143122: Volcano iFR Harvest Software (Offline)

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Feb 20, 2015 after 112 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K934139 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133323: Volcano Ifr Modality, Volcano Corporation (2014) Summary page 4.

## Indications for use
The Volcano iFR® Harvest Modality is an offline analysis tool of the currently marketed vasodilator-free pressure measurement module, iFR® Modality of the Volcano s5/s5i/CORE and CORE Mobile systems. It is intended to calculate iFR values from hyperemia-free FFR pressure recordings in a laptop or desktop setting only.

Source page: https://510kreport.com/device/K143122
Methodology: https://510kreport.com/methodology