# K960338: Stereotactic Body Frame

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Apr 23, 1996 after 90 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 K935300 (1994). 2 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1), Radionics, Inc. (1995) Summary page 2.
- K935300: Vac-Lok Immobilization System, Medtec, Inc. (1994) Summary page 2.

## Most influential descendants
- K970291: Accessories to the Stereotactic Body Fram (1997), 9 descendants of its own
- K982463: Extracranial Radiotherapy System (1998), 8 descendants of its own
- K991336: Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy (1999), 7 descendants of its own
- 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

## Indications for use
The Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.

Source page: https://510kreport.com/device/K960338
Methodology: https://510kreport.com/methodology