Accuray Precision Treatment Planning System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171086 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 Therapy Treatment Planning Device designed to generate and optimize radiation therapy plans for precise delivery. It integrates advanced algorithms to model tumor geometry, dose distribution, and patient anatomy, enabling clinicians to tailor treatment plans to complex cases, including those requiring real-time motion tracking or helical delivery.
This system is intended for use in radiation oncology departments and is supplied as software-only, requiring installation on compatible hardware platforms such as the CyberKnife or Radixact Systems. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDD compliance, ensuring adherence to stringent safety and performance standards. The device is non-sterile and intended for single-use in planning workflows, with no MRI compatibility specified.
Frequently asked questions
What types of radiation therapy systems is the Accuray Precision Treatment Planning System designed to integrate with?
The Accuray Precision Treatment Planning System is specifically designed as a software-only solution to integrate with compatible hardware platforms like the CyberKnife and Radixact Systems. It is not a standalone device but rather a planning tool that enhances the functionality of these systems by generating and optimizing radiation therapy plans.
Is the Accuray Precision Treatment Planning System intended for repeated use across multiple patients, or is it single-use?
The Accuray Precision Treatment Planning System is intended for single-use in planning workflows. While it is a software-based solution, its usage is tied to individual treatment planning sessions, meaning it is not designed for continuous reuse across multiple patients without reinstallation or updates.
Does the Accuray Precision Treatment Planning System require any special handling or storage conditions?
Since the Accuray Precision Treatment Planning System is a non-sterile software-only solution, it does not require sterile storage or handling. However, it should be installed on compatible hardware platforms in a controlled environment to ensure optimal performance and data integrity. No specific temperature or humidity requirements are mentioned in the provided data.
What regulatory pathways has the Accuray Precision Treatment Planning System followed, and what does this imply for its use?
The Accuray Precision Treatment Planning System has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD), indicating it meets stringent safety and performance standards for Class II devices. This implies that it has undergone rigorous review by regulatory authorities to ensure its suitability for use in radiation oncology departments, particularly for generating and optimizing radiation therapy plans.
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 PRECISION™ TREATMENT PLANNING SYSTEM AND iDMS ... - MedicalExpo
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 | K171086 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (2)
- FDA 510(k) K171086 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026