# K953391: Treatment Management System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 7, 1996 after 232 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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
Longest line of descent: 1 generation back to K914926 (1992). 1 ancestor in all.
27 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914926: Scandiplan - Version 338, Scanditronix, Inc. (1992). Our OCR of the scanned summary read K814926, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SCANDIPLAN 3-Dimensional Radiation Therapy Treatment Planning System”.

## 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
TMS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 4 to 50MV, as well as Cobalt-60, and electron energies from 4 to 50 MeV. TMS will plan the 3D radiotherapy treatment approaches of combined modality plans, asymmetric and noncoplanar fields; total body irradiation (TBI); multi-leaf collimators (MLC); motorized and dynamic wedges; customized blocking; compensating filters (CF); and bolus.

Source page: https://510kreport.com/device/K953391
Methodology: https://510kreport.com/methodology