# K132558: Sync-RX System

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Dec 12, 2013 after 119 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: 9 generations back to K922804 (1992). 66 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100849: Sync-RX System, Model AS00010, Sync-Rx, Ltd. (2010) Summary page 1.
- K123529: Artis Q and Q.Zen- Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2013) Summary page 1.

## Most influential descendants
- K151904: SyncVision System (2015), 2 descendants of its own
- K161756: SyncVision System (2016), 1 descendant of its own
- K172574: SyncVision System (2017), 0 descendants of its own

## 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 Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows: a) To provide quantitative information regarding the calculated dimensions of arterial segments. b) To enhance visualization of the stent deployment region. c) To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. d) To obtain a co-registration of an anglographic x-ray image and IVUS images.

Source page: https://510kreport.com/device/K132558
Methodology: https://510kreport.com/methodology