# K150441: Volcano iFR Modality, iFR Scout feature

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Mar 20, 2015 after 28 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.
9 later devices descend from it; 2 cite it directly.
0 of 58 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.

## Most influential descendants
- 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
- K190078: IntraSight (2019), 2 descendants of its own
- K153369: SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz (2015), 2 descendants of its own
- K170385: CORE M2 Vascular System (2017), 1 descendant of its own

## Indications for use
The iFR® Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

Source page: https://510kreport.com/device/K150441
Methodology: https://510kreport.com/methodology