Identifiers
- 510(k) Number
- K121934 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 TomoTherapy Treatment System is a helical radiation therapy platform that delivers image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT). It provides 360-degree treatment delivery, allowing for superior dose sculpting and minimized radiation exposure to healthy tissues.
The system is manufactured by Accuray Incorporated and is authorized under FDA 510K clearance. It is a Class II medical device used in radiology, with multiple registration numbers and a product code of IYE. The device is designed for use in radiation oncology settings, providing precise radiation therapy treatments.
Frequently asked questions
What is the TomoTherapy Treatment System used for?
The TomoTherapy Treatment System is a helical radiation therapy platform used in radiation oncology settings. It delivers image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT) with 360-degree treatment delivery capabilities, allowing for superior dose sculpting and minimized radiation exposure to healthy tissues.
How is the TomoTherapy Treatment System supplied and what are its sterility requirements?
The TomoTherapy Treatment System is a Class II medical device manufactured by Accuray Incorporated. It is supplied as a complete radiation therapy platform for clinical settings. The device is designed for use in radiology departments and does not require sterile handling as it is not a single-use device that comes into direct contact with patients during treatment.
What regulatory authorization does the TomoTherapy Treatment System have?
The TomoTherapy Treatment System is authorized under FDA 510K clearance with decision code SESE, indicating it is substantially equivalent to other legally marketed devices. It has multiple registration numbers and product code IYE, classified as a Class II medical device in radiology with FDA clearance received on 2012-07-02 and decision date of 2012-08-29.
What are the key features of the TomoTherapy Treatment System?
The TomoTherapy Treatment System provides 360-degree treatment delivery, allowing for superior dose sculpting and minimized radiation exposure to healthy tissues. It combines image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT) capabilities, making it suitable for precise radiation therapy treatments in oncology settings.
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: Accuray TomoTherapy® System - Medequips, Accuray | Innovative Radiotherapy Treatments, Radixact Radiation Therapy - Accuray, TomoTherapy (Accuray) | medikainc
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121934 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (1)
- FDA 510(k) K121934 24 fields · synced Sep 24, 2026