# K103616: Pinpoint Stereotactic Head and Neck Localizer

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Jan 25, 2011 after 46 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: 4 generations back to K934523 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081935: Stereotactic Head and Neck Localizer, Model 50-100, Aktina Medical Physics Corp. (2008) Summary page 1.

## Indications for use
This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system provides cranial and head and neck fixation and stereotactic localization with automatic software fiducial localization. It is intended to be used during both Computed Tomography (acquisition of the imaging series used for the patient's treatment plan) and each of the patient radiation treatments.

Source page: https://510kreport.com/device/K103616
Methodology: https://510kreport.com/methodology