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BrainScan Radiosurgery Module

by Brainlab

510(k) K920879

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920879 Date29 Dec 1992ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-2251-2009 FDA Unclassified (pre-2012) initiated 12 Aug 2009 on shared 510(k) K920879

    Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Cleared FDA 510(k) K920879
  2. Recall initiated FDA recalls Z-2251-2009

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  • Withdrawn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
IYE
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 BrainScan Radiosurgery Module is a medical charged-particle radiation therapy system designed to accelerate high-energy charged particles (e.g., electrons and protons) for use in radiation therapy. It functions as a specialized component within a radiosurgery or radiotherapy treatment planning system, enabling precise targeting of lesions or tumors with focused radiation doses.

This module is intended for use in radiology settings and has been cleared by the FDA under the 510(k) pathway as substantially equivalent to prior devices. It is supplied as part of an integrated system and is not intended for standalone use. The device is classified under product code IYE and is regulated under 21 CFR 892.5050. No third-party review was required for this submission.

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Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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