# K121530: Bodyfix System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik GmbH
- Decided: Jun 20, 2012 after 27 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 K013391 (2002). 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)
- K013391: Bodyfix, Medical Intelligence Medizintechnik GmbH (2002) Summary page 1.

## Indications for use
This product is intended to be used by radiologists and surgeons for the following: * Patient positioning and immobilization * Stereotactic diagnostic localization * Patient positioning and immobilization device for stereotactic radiotherapy of extracranial targets

Source page: https://510kreport.com/device/K121530
Methodology: https://510kreport.com/methodology