# K031631: Stereotactic Body Frame, Model Cod. 70-1A

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line USA, Inc.
- Decided: Jul 18, 2003 after 52 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.

Source page: https://510kreport.com/device/K031631
Methodology: https://510kreport.com/methodology