# K962892: Helax TMS Brachytherapy, Version 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 29, 1996 after 97 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K915622 (1992). 1 ancestor in all.
25 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915622: Plato Brachytheraphy Treatment Planning System, Nucletron-Oldelft Corp. (1992) Summary page 1.

## Most influential descendants
- K993766: Helax-TMS V 5.0 Radiation Therapy Treatment Planning System (1999), 24 descendants of its own
- K010682: Helax-TMS V 5.1 Radiation Therapy Treatment Planning System (2001), 23 descendants of its own
- K020971: DCM 2.0 (2002), 22 descendants of its own
- K130617: Raystation (2013), 21 descendants of its own
- K140187: Ray Station (2014), 19 descendants of its own

## Indications for use
The TMS Brachytherapy Module, Version 3.0, is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing interstitial or intracavitary treatment in the Oncology clinic. The system software is designed to function as an integrated part of the TMS (Treatment Management System) radiotherapy treatment planning system (K953391). The TMS Brachytherapy Module is used for planning the treatment only, not for performing the treatment.

Source page: https://510kreport.com/device/K962892
Methodology: https://510kreport.com/methodology