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IBU Integrated Brachy Therapy Unit

by Nucletron Corp.

510(k) K973848

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973848 Date22 Jan 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KPQ
Device Class
Class II
Regulation
21 CFR Part 892.5840
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 IBU Integrated Brachy Therapy Unit is a Radiation Therapy Simulation System (product code KPQ) designed for brachytherapy treatment planning. It combines fluoroscopic and radiographic imaging capabilities to visualize, localize, and confirm the volume and dimensions of brachytherapy irradiation fields. This system integrates a gantry-mounted L-arm and C-arm configuration to enhance precision in treatment planning for radiation oncology. Its classification as a Class II device reflects specialized controls to ensure safety and performance in clinical radiation therapy applications.

The IBU is intended for use in radiology departments within clinical settings, where it supports pre-treatment imaging and verification for brachytherapy procedures. Supplied as a reusable medical device, it requires adherence to sterile field protocols and proper maintenance to ensure imaging accuracy. The system is authorized under FDA 510(k) clearance (K973848), with a decision date of January 22, 1998, and falls under the regulatory framework for radiation therapy systems (regulation number 892.5840). No additional sterility or single-use specifications are indicated in the regulatory data.

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