# K020294: Motion Tracking

- Pathway: 510(k) (Traditional)
- Applicant: Accuray, Inc.
- Decided: Apr 22, 2002 after 84 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864886 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011024: Cyberknife System, Accuray, Inc. (2001) Summary page 1.
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.

## Recalls of this device
- Mar 16, 2009 · Not classified · Z-0909-2011: The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with
- Mar 16, 2009 · Not classified · Z-0908-2011: The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with

## Indications for use
To provide an option to the CyberKnife System which will enable 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/K020294
Methodology: https://510kreport.com/methodology