# K961902: Siemens Beam Shaper

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 8, 1996 after 84 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
Longest line of descent: 1 generation back to K953894 (1995). 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)
- K953894: Siemens Multileaf Collimator, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K982952: Imfast (1999), 0 descendants of its own

## Indications for use
The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system.

Source page: https://510kreport.com/device/K961902
Methodology: https://510kreport.com/methodology