# K050372: Visitrak, Version 1, Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Math Resolutions, LLC
- Decided: Mar 25, 2005 after 39 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970464 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970464: P Reference TPS (Treatment Planning Software) 1.1, Northwest Medical Physics Equipment, Inc. (1997) Summary page 1.

## Indications for use
This product is to be used by radiation therapy oncologist or staff under their direction to locate the position relative to the patient of the isocenter of a treatment beam on a gantry mounted radiation therapy treatment machine. Some internal or external marker must be visible on both a radiograph of the patient taken at the time of treatment and the images used for the treatment plan in order to use this software to align the marker image on the radiograph with the plan to find the proper patient support system coordinates. Only a translation along the couch lateral, longitudinal, and height directions are considered and solved for. Possible rotations or repositioning of the patient are not considered.

Source page: https://510kreport.com/device/K050372
Methodology: https://510kreport.com/methodology