# K190626: SyncVision System

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Apr 12, 2019 after 32 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K253714: IntraSight Plus (2026), 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

Source page: https://510kreport.com/device/K190626
Methodology: https://510kreport.com/methodology