# K970303: Saturne Multileaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Apr 25, 1997 after 88 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Multileaf collimators produced by Varian Associates: named in the summary without a submission number
- (no number) Multileaf collimators produced by Philips Medical Systems: named in the summary without a submission number

## Indications for use
The Saturne Multileaf collimator is intended to be uged for radiation therapy.

Source page: https://510kreport.com/device/K970303
Methodology: https://510kreport.com/methodology