# K100849: Sync-RX System, Model AS00010

- Pathway: 510(k) (Traditional)
- Applicant: Sync-Rx, Ltd.
- Decided: May 21, 2010 after 56 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K922804 (1992). 26 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082907: IC-Pro System, Version 3.1.0.4, Paieon, Inc. (2008) Summary page 1.
- K915542: Qca Plus, Sanders Data Systems, LLC (1992) Summary page 1.

## Most influential descendants
- K132558: Sync-RX System (2013), 3 descendants of its own
- 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

## 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) Td enhande visualization of the stent deployment region. c) To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.

Source page: https://510kreport.com/device/K100849
Methodology: https://510kreport.com/methodology