Accuray Precision Treatment Planning System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212794 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 Accuray Precision Treatment Planning System is a Radiation Treatment Planning Device designed to generate and optimize radiation therapy plans for linear accelerators and other radiotherapy platforms. It integrates advanced imaging, dose calculation algorithms, and adaptive planning tools to support precise targeting of tumors while minimizing exposure to surrounding healthy tissue.
This system is supplied as software installed on a dedicated hardware platform and is intended for use in radiation oncology departments within hospitals or specialized cancer treatment centers. It operates as a reusable, non-sterile device, with MRI safety classified as non-MRI conditional (per manufacturer specifications). The system requires specialized training for operation and is authorized under FDA 510(k) clearance and MDD compliance, adhering to regulatory standards for medical imaging and radiotherapy planning.
Frequently asked questions
What types of radiation therapy platforms is the Accuray Precision Treatment Planning System designed to support?
The Accuray Precision Treatment Planning System is specifically designed to generate and optimize radiation therapy plans for linear accelerators and other radiotherapy platforms. It integrates advanced imaging and adaptive planning tools to ensure precise tumor targeting while minimizing exposure to surrounding healthy tissue, making it versatile for various radiation oncology treatments.
Is the Accuray Precision Treatment Planning System reusable or single-use, and what are its sterility requirements?
The Accuray Precision Treatment Planning System is a reusable, non-sterile device. Since it operates as software installed on dedicated hardware, sterility is not applicable, and no sterilization procedures are required. However, the hardware platform must be maintained in a clean and functional state for clinical use.
What kind of training is required to operate the Accuray Precision Treatment Planning System?
The Accuray Precision Treatment Planning System requires specialized training for operation due to its advanced imaging, dose calculation algorithms, and adaptive planning tools. Clinicians and staff must undergo proper training to ensure accurate and safe use in radiation oncology departments.
How is the system classified in terms of MRI safety, and where is it intended for use?
The Accuray Precision Treatment Planning System is classified as non-MRI conditional, meaning it should not be used in MRI environments. It is intended for use exclusively in radiation oncology departments within hospitals or specialized cancer treatment centers.
What regulatory pathways does the Accuray Precision Treatment Planning System follow, and what does that mean for its use?
The system is authorized under FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU and U.S. standards for radiation treatment planning devices, ensuring its safety and effectiveness for clinical use in radiation oncology.
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: Precision Radiotherapy Treatment Planning - Accuray, Accuray | Innovative Radiotherapy Treatments, Accuray Precision Treatment Planning System: Pricing, Reviews ..., Accuray Announces Approval of the Accuray Precision® Treatment Planning ...
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 | K212794 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (2)
- FDA 510(k) K212794 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026