# K982513: MX Mevatron

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 31, 1998 after 11 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882729 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882729: Mevatron, M 2 Class, Siemens Medical Laboratories, Inc. (1988) Summary page 1.

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

## Recalls of this device
- Feb 18, 2020 · Class II · Z-1678-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Feb 18, 2020 · Class II · Z-1679-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

## Indications for use
The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The depth of penetration emulating from the MEVATRON MX ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

Source page: https://510kreport.com/device/K982513
Methodology: https://510kreport.com/methodology