# K993766: Helax-TMS V 5.0 Radiation Therapy Treatment Planning System

- Pathway: 510(k) (Special)
- Applicant: Helax AB
- Decided: Dec 8, 1999 after 30 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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
Longest line of descent: 3 generations back to K884261 (1989). 12 ancestors in all.
24 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962892: Helax TMS Brachytherapy, Version 3.0, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.
- K953391: Treatment Management System, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.
- K984532: Cadplan Helios Option 6.0, Varian Medical Systems, Inc. (1999) Summary page 1.
- K940663: Peacock Plan, Nomos Corp. (1996) Summary page 1.
- K963258: Peacock System, Nomos Corp. (1996) Summary page 1.

## Most influential descendants
- 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
- K141860: Raystation (2014), 17 descendants of its own

## Indications for use
Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning but not treatment, of patients undergoing external beam or Brachytherapy treatment in the Oncology clinic. The system is designed to lead the user through a logical flow planning process. Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with (i) linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 to 50MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking; compensating filters; and bolus. (ii) Brachytherapy units for patients undergoing interstitial or intracavitary treatment in the Oncology clinic. Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, as well as record and verify systems.

Source page: https://510kreport.com/device/K993766
Methodology: https://510kreport.com/methodology