# K042875: Navigator

- Pathway: 510(k) (Traditional)
- Applicant: Nomos Corp.
- Decided: Jul 1, 2005 after 256 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: 3 generations back to K851659 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000246: Radiocameras Extracranial System, Surgical Navigation Technologies, Inc. (2000) Summary page 1.
- K994355: Radiocameras System Head/Neck Application, Surgical Navigation Technologies, Inc. (2000) Summary page 1.
- K981424: Nomos Bat Ultrasound Localization and Positioning System, Nomos Corp. (1998) Summary page 1.

## Indications for use
The nTRAK Patient Positioning and Monitoring System is Intended for use with a linear accelerator in Radiation Therapy(RT)/ stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.

Source page: https://510kreport.com/device/K042875
Methodology: https://510kreport.com/methodology