Tomotherapy Treatment System
FDA 510(k) K121934 · Accuray Incorporated
510(k) numberK121934
Submission
- Device name
- Tomotherapy Treatment System
- Applicant
- Accuray Incorporated
Madison, WI, US - Received
- July 2, 2012
- Decision date
- August 29, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Tomotherapy Treatment System cleared by the FDA?
Tomotherapy Treatment System (K121934) received a 510(k) decision of Substantially Equivalent on August 29, 2012, 58 days after the submission was received.
What is the product code of K121934?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.