Blue Phantom PT
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Blue Phantom PT EUDAMED
- Device Name
- Blue Phantom PT EUDAMED
- Model / Reference
- DP80-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EIBADP800000 EUDAMED
- Basic UDI-DI
- ++EIBABPPTZ7 EUDAMED
- Direct Marketing DI
- EIBADP800000 EUDAMED
- 510(k) Number
- K191821 FDA 510(k)
- FDA Product Code
- LHN FDA 510(k)
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Blue Phantom PT is a Radiation Therapy, Charged-Particle, Medical System designed for high-resolution depth dose measurements in pencil beam scanning applications. It serves as a phantom model for beam commissioning and quality assurance (QA) in radiation therapy, enabling precise verification of dose distributions and treatment planning accuracy.
This device is supplied as a reusable phantom for use in clinical settings, including radiation oncology departments. It is intended for integration with linear accelerators and other charged-particle therapy systems, adhering to regulatory standards under FDA 510(k) clearance and MDR compliance. The Blue Phantom PT is classified as a Class II medical device and requires proper storage and handling to maintain measurement integrity.
Frequently asked questions
What is the Blue Phantom PT primarily used for in clinical radiation therapy settings?
The Blue Phantom PT is designed specifically for high-resolution depth dose measurements in pencil beam scanning applications within radiation therapy. It serves as a phantom model to verify dose distributions and ensure the accuracy of treatment planning during beam commissioning and quality assurance (QA) processes. This helps clinicians validate that the radiation delivery system is performing as intended before patient treatment.
Is the Blue Phantom PT intended for single-use or can it be reused in clinical environments?
The Blue Phantom PT is supplied as a reusable phantom for clinical settings, including radiation oncology departments. Since it is intended for repeated use in beam commissioning and quality assurance, proper storage and handling are required to maintain its measurement integrity and ensure consistent performance over time.
How does the Blue Phantom PT integrate with existing radiation therapy systems?
The Blue Phantom PT is designed to integrate with linear accelerators and other charged-particle therapy systems. Its purpose is to provide a standardized phantom model for verifying dose distributions and treatment planning accuracy, ensuring that the device’s measurements align with the clinical systems already in use for radiation therapy.
What regulatory pathways does the Blue Phantom PT follow for approval?
The Blue Phantom PT has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). It is classified as a Class II medical device, which requires adherence to specific regulatory standards to ensure safety and performance in clinical applications.
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: Blue Phantom PT - High resolution: IBA Dosimetry, IBA launches myQA Blue Phantom³ for radiation therapy quality assurance, PDF Press Release IBA launches myQA Blue Phantom³ for radiation therapy ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191821 | Class II | Active |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
Sources (2)
- FDA 510(k) K191821 24 fields · synced Oct 6, 2026
- EUDAMED 228d38b3-3642-48b3-8209-b812f6e5d087 61 fields · synced Jul 21, 2026