# K172574: SyncVision System

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Oct 5, 2017 after 38 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K922804 (1992). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161756: SyncVision System, Volcano Corporation (2016) Summary page 4.

## Recalls of this device
- Jan 19, 2022 · Class II · Z-0885-2022: If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cau

## Indications for use
The SyncVision System is an image acquisition and processing system. It is indicated for use as follows: • To provide quantitative information regarding the calculated dimensions of arterial segments. • To enhance visualization of the stent deployment region. • To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. • To obtain a co-registration of an angiographic x-ray image and IVUS images. • To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

Source page: https://510kreport.com/device/K172574
Methodology: https://510kreport.com/methodology