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Simuplan Treatment Planning System, Model V. 7.5

by Simuplan S.L.

510(k) K030821

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 NumberK030821 Date17 Sep 2003ClearedStatusActive

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  • Withdrawn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
MUJ
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Simuplan Treatment Planning System, Model V. 7.5, is a System, Planning, Radiation Therapy Treatment device, as classified by the FDA. It is a software-based solution designed to generate and optimize treatment plans for radiation therapy, including external beam and brachytherapy, by calculating dose distributions and target volumes for patient-specific protocols.

This system is intended for use in radiology settings and operates as a non-sterile, reusable software platform. It requires validation and confirmation by a physician before clinical application. The device holds an FDA 510(k) clearance under product code MUJ and regulation number 892.5050, with no third-party involvement in its regulatory submission. Installation and use are restricted to qualified medical professionals in accredited radiation oncology environments.

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