# K081935: Stereotactic Head and Neck Localizer, Model 50-100

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Oct 7, 2008 after 92 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 K934523 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030439: Headfix, Medical Intelligence Medizintechnik GmbH (2003) Summary page 1.
- K991237: Xplan-2 with Head and Neck Localizer, Model HNL, Radionics, Inc. (1999) Summary page 1.
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1), Radionics, Inc. (1995) Summary page 1.
- K945903: Brainlab Mask System, Brainlab Med. Computersysteme GmbH (1995) Summary page 1.
- K954861: Brainlab CT/X-Ray Localizer, Brainlab Med. Computersysteme GmbH (1996) Summary page 1.
- K073018: Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight, Brainlab AG (2008) Summary page 1.

## Most influential descendants
- K103616: Pinpoint Stereotactic Head and Neck Localizer (2011), 0 descendants of its own

## 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/K081935
Methodology: https://510kreport.com/methodology