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Intuition Image

by Brainlab AG

510(k) K032511

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

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 NumberK032511 Date21 Jan 2004ClearedStatusActive

Official records

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  • Withdrawn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
LHN
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 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 Intuition Image is a Medical Charged-Particle Radiation Therapy System, designed for precise delivery of radiation therapy using charged particles. It integrates imaging and treatment planning capabilities to enhance accuracy in radiotherapy for cancer treatment, aligning with FDA-recognized standards for radiation therapy devices. This system falls under the classification of a System, Radiation Therapy, Charged-Particle, Medical device, ensuring compliance with regulatory requirements for high-risk medical applications.

The Intuition Image is supplied as a Class II medical device, regulated under 21 CFR 892.5050 and cleared via FDA 510(k) submission (K032511). It is intended for use in radiology settings, where its advanced imaging and treatment planning functionalities support targeted radiation therapy. The device is not described as single-use or reusable in the regulatory data, though its design suggests it is intended for institutional use in controlled environments. No specific sterility or MRI safety information is provided in the available documentation.

Similar devices

Other devices filed under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical).

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