# K973963: 120 Leaf Multileaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Electronics America, Inc.
- Decided: Jan 14, 1998 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
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) Mitsubishi multileaf collimator: named in the summary without a submission number
- (no number) multileaf collimator manufactured and distributed by Varian Associates Inc.: named in the summary without a submission number

## Indications for use
The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.

Source page: https://510kreport.com/device/K973963
Methodology: https://510kreport.com/methodology