# K013391: Bodyfix

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik GmbH
- Decided: Jan 11, 2002 after 88 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Med-Tec Inc.'s BodyFIX System: named in the summary without a submission number
- (no number) Elekta Instrument AB’s Stereotactic Body Frame and accessories: named in the summary without a submission number
- (no number) Midco's BodylLoc: named in the summary without a submission number

## Most influential descendants
- K100691: Omni V SBRT Positioning System, Model RT-4500 (2010), 6 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
This product is intended for use by radiologists and surgeons for: Patient positioning and immobilization Stereotactic diagnostic localization Stereotactic radiotherapy of extracranial targets

Source page: https://510kreport.com/device/K013391
Methodology: https://510kreport.com/methodology