# K120233: Synchrony Respiratory Tracking System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Mar 9, 2012 after 44 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 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
- K122451: Exactrac Vero (2012), 10 descendants of its own
- K131965: XVI R5.0 (2013), 8 descendants of its own
- K151561: Leksell Gamma Knife Icon (2015), 4 descendants of its own
- K160440: Leksell Gamma Knife Icon (2016), 3 descendants of its own
- K173789: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (2018), 2 descendants of its own

## Recalls of this device
- Jan 22, 2016 · Class II · Z-0771-2016: The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a 

## Indications for use
The Synchranyo Respiratory Tracking System provides an option to the CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System that enables dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.

Source page: https://510kreport.com/device/K120233
Methodology: https://510kreport.com/methodology