# K970291: Accessories to the Stereotactic Body Fram

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Apr 24, 1997 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: 2 generations back to K935300 (1994). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960338: Stereotactic Body Frame, Elekta Instrument AB (1996) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Accessories to the Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extra cranial targets.

Source page: https://510kreport.com/device/K970291
Methodology: https://510kreport.com/methodology