# K073018: Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jan 23, 2008 after 90 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934657 (1994). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934657: Brainlab Linac Hardware, Brainlab Med. Computersysteme GmbH (1994) Summary page 1.

## Most influential descendants
- K081935: Stereotactic Head and Neck Localizer, Model 50-100 (2008), 1 descendant of its own
- K103616: Pinpoint Stereotactic Head and Neck Localizer (2011), 0 descendants of its own

## Recalls of this device
- Jul 16, 2013 · Class II · Z-2083-2013: The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.

## Indications for use
The Target Positioner (TaPo) is used to position the patient for the stereotactic radiotherapy/radiosurgery. The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.

Source page: https://510kreport.com/device/K073018
Methodology: https://510kreport.com/methodology