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BrainScan Radiosurgery Module

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920879

by Brainlab

Identifiers

510(k) Number
K920879 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Radiosurgery: Increasing the impact of SRS & SBRT | Brainlab, BRAINSCAN RADIOSURGERY MODULE (K920879) — FDA 510(k) | Innolitics, Elements: Radiotherapy & Radiosurgery Treatment Planning | Brainlab

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab

Sources (1)

  • FDA 510(k) K920879 24 fields · synced Sep 19, 2026