Intuition Image
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K032511 FDA 510(k)
- FDA Product Code
- LHN 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 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.
Frequently asked questions
What type of radiation therapy does the Intuition Image system deliver, and how does it improve treatment accuracy?
The Intuition Image is a Medical Charged-Particle Radiation Therapy System, meaning it delivers radiation using charged particles (such as protons) rather than traditional X-rays. This system integrates advanced imaging and treatment planning capabilities, allowing for highly precise targeting of tumors while minimizing exposure to surrounding healthy tissue. The integration of imaging ensures real-time alignment and verification, which is critical for complex cases like pediatric or brain cancers where accuracy is paramount.
Is the Intuition Image system designed for single-use or repeated use in a clinical setting?
The Intuition Image is not explicitly described as single-use or reusable in the regulatory data, but its classification as a Class II medical device for institutional use suggests it is intended for controlled, multi-patient environments—such as hospitals or specialized radiation oncology centers. The system’s design implies it is meant for repeated use within a facility, with proper maintenance protocols to ensure consistent performance and safety.
What regulatory pathway was followed for FDA clearance of the Intuition Image, and what does that mean for clinicians?
The Intuition Image received FDA 510(k) clearance (K032511) under the Traditional 510(k) Review pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms the system meets FDA standards for Charged-Particle Radiation Therapy Systems and aligns with 21 CFR 892.5050, ensuring it is safe and effective for its intended use in radiology settings. Clinicians can rely on this approval as validation of its technical and safety compliance.
Are there any specific storage requirements or considerations for the Intuition Image system?
The provided data does not specify sterility requirements or storage conditions for the Intuition Image system, as it is not described as a sterile device. However, as a high-precision radiation therapy system, it should be stored in a clean, controlled environment—protected from physical damage, electromagnetic interference, and extreme temperatures—to maintain calibration and performance. The system’s institutional use implies it requires proper facility infrastructure, including dedicated space and maintenance protocols.
How does the Intuition Image system differ from conventional X-ray-based radiation therapy?
Unlike conventional X-ray radiation therapy, which uses photons to deliver radiation in a broader beam, the Intuition Image system uses charged particles (e.g., protons), allowing for greater precision and dose conformity to the tumor. This reduces exposure to healthy tissue, which is particularly advantageous for treating sensitive areas like the brain, spinal cord, or pediatric patients. The system’s integration of imaging and treatment planning further enhances accuracy by enabling real-time verification of patient positioning and tumor localization before and during therapy.
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: INTUITION IMAGE (K032511) — FDA 510 (k) | Innolitics, INTUITION IMAGE 510 (k) K032511 - FDA.report, Brainlab Intuition Image - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032511 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K032511 24 fields · synced Sep 20, 2026