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Treatment Management System

by Siemens Medical Solutions USA, Inc.

510(k) K953391

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953391 Date7 Mar 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LHN
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Treatment Management System is a Radiation Therapy, Charged-Particle, Medical System designed to plan and manage radiation treatment delivery. It integrates with linear accelerators and teletherapy devices, including those using x-ray energies (4–50 MV) and electron energies (4–20 MeV), as well as Cobalt-60 sources, to optimize 3D radiation treatment planning and dose distribution.

This system is supplied as a software-based solution for use in radiation oncology settings, requiring integration with compatible radiation therapy equipment. It is intended for single-use in clinical workflows, though its regulatory status includes FDA 510(k) clearance under Traditional review (K953391) and compliance with 21 CFR 892.5050. No sterility or MRI safety classifications are specified, and its use is governed by adherence to radiation safety protocols and institutional quality assurance standards.

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