Pinnacle3 Radiation Therapy Planning System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130992 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 Pinnacle³ Radiation Therapy Planning System is a radiation therapy treatment planning workstation designed to assist clinicians in creating and evaluating radiation treatment plans. It integrates advanced computational algorithms and imaging data to optimize dose distribution for precise tumor targeting while minimizing exposure to healthy tissue, supporting modalities such as photon and proton therapy.
This software operates on a Solaris UNIX-compliant system and is intended for use in radiation oncology departments. It is supplied as a standalone software package and is classified as a Class II medical device under FDA regulations (510(k) clearance) and the EU Medical Device Directive (MDD). The system is non-sterile, reusable, and does not contain MRI-compatible components. No specific single-use or sterility requirements are noted in the regulatory submissions.
Frequently asked questions
What is the primary purpose of the Pinnacle³ Radiation Therapy Planning System in a clinical setting?
The Pinnacle³ Radiation Therapy Planning System is designed to assist clinicians in creating and evaluating radiation treatment plans. It integrates advanced computational algorithms with imaging data to optimize dose distribution, ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissue. This supports multiple therapy modalities, including photon and proton therapy, making it a critical tool for radiation oncology departments.
How is the Pinnacle³ Radiation Therapy Planning System supplied, and what are its sterility and reuse requirements?
The system is supplied as a standalone software package and operates on a Solaris UNIX-compliant platform. It is classified as a non-sterile, reusable device. Since it is software-based and does not involve disposable or sterile components, no single-use or sterility requirements apply beyond standard IT and system hygiene protocols for medical environments.
What regulatory pathways has the Pinnacle³ Radiation Therapy Planning System undergone, and where can it be used?
The Pinnacle³ Radiation Therapy Planning System has received FDA clearance through a 510(k) submission, classified as a Class II medical device. It is also compliant with the EU Medical Device Directive (MDD). This regulatory clearance allows its use in radiation oncology departments in the United States and other regions where applicable regulatory standards are met, such as those aligned with the MDD.
Does the Pinnacle³ Radiation Therapy Planning System include any hardware components that are MRI-compatible?
No, the Pinnacle³ Radiation Therapy Planning System does not contain any MRI-compatible components. Since it is a software-based workstation, its compatibility is limited to non-MRI environments, and it should not be used in proximity to MRI systems where electromagnetic interference could occur.
What types of radiation therapy modalities does the Pinnacle³ Radiation Therapy Planning System support?
The system is designed to support both photon and proton therapy modalities. By leveraging advanced computational algorithms and imaging data integration, it helps clinicians optimize treatment plans for these modalities, ensuring precise dose delivery to tumors while sparing adjacent healthy tissue.
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: PDF Instructions for Use - Philips, PDF Pinnacle Planning IFU, Philips - Pinnacle³ 9.8
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130992 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (2)
- FDA 510(k) K130992 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026