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Plato Brachytheraphy Treatment Planning System

by Nucletron-Oldelft Corp.

510(k) K915622

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 NumberK915622 Date25 Sep 1992ClearedStatusActive

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  • Withdrawn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
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
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 Plato Brachytherapy Treatment Planning System is a radiation therapy treatment planning system designed for brachytherapy, a form of internal radiotherapy. It facilitates the precise calculation and optimization of radiation dose distributions for interstitial, intracavitary, and surface applicators, ensuring targeted delivery to malignant tissues while minimizing exposure to healthy tissue. The system integrates computational algorithms to model dose distributions based on radionuclide sources and applicator configurations, supporting personalized treatment planning for oncological applications.

This system is intended for use in radiology departments and radiation oncology clinics, where it is operated by trained medical physicists or radiation oncologists. Supplied as a software-based solution, it requires compatible hardware for execution and does not involve single-use or reusable consumables. The device operates under FDA 510(k) clearance (K915622) and falls under product code JAQ, classified as a Class II medical device under 21 CFR 892.5700. No specific sterility or MRI safety requirements are noted in the regulatory data.

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