# K034051: Dynatrac, Cod. 50-1A

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line USA, Inc.
- Decided: Apr 5, 2004 after 97 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 K983660 (1999). 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)
- K983660: Exactrac (Brainlab Patient Positioning System), Brainlab, Inc. (1999) Summary page 1.

## Indications for use
Patient Tracking System is an optical system for tracking patient position for before and during radiotherapy. It is an accessory to linear accelerators used radiotherapy. It is indicated for use in the conduct of 3 dimensional radiotherapy.

Source page: https://510kreport.com/device/K034051
Methodology: https://510kreport.com/methodology