# K970137: Exl-12SP,12DP,15DP,20DP Linac

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Electronics America, Inc.
- Decided: Apr 15, 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K023636: Blocking Tray (2002), 0 descendants of its own

## Indications for use
The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.

Source page: https://510kreport.com/device/K970137
Methodology: https://510kreport.com/methodology