# K133323: Volcano Ifr Modality

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Mar 14, 2014 after 136 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: 9 generations back to K934139 (1995). 47 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System, Volcano Corporation (2013) Summary page 1.

## Most influential descendants
- K150441: Volcano iFR Modality, iFR Scout feature (2015), 9 descendants of its own
- K170133: FFR V2.5 (2017), 5 descendants of its own
- K173860: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (2018), 4 descendants of its own
- K183099: QUANTIEN Measurement System (2019), 3 descendants of its own
- K183320: Ilumien Optis, Optis Integrated, Optis Mobile (2019), 2 descendants of its own

## Indications for use
The iFR* Modality of the s5/sSiCORE/CORE Mobile Precision Guided Therapy Systemis indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFRO Modality is intended to be used in conjunction with currently marketed Volcano pressurewires.

Source page: https://510kreport.com/device/K133323
Methodology: https://510kreport.com/methodology