# K970564: Dynamic Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Electronics America, Inc.
- Decided: May 12, 1997 after 88 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) EXL series of Mitsubishi Linear Accelerators utilizing klystron and magnetron power supplies and conventional hard-wired control consoles: named in the summary without a submission number

## Indications for use
The Dynamic Wedge system is intended to be used with MLC and Mitsubishi linear accelerators with computerized consoles to provide the effective isodose curve and replace the need for traditional hard wedges.

Source page: https://510kreport.com/device/K970564
Methodology: https://510kreport.com/methodology