Accuray Precision Treatment Planning System
FDA 510(k) K212794 · Accuray Incorporated
510(k) numberK212794
Submission
- Device name
- Accuray Precision Treatment Planning System
- Applicant
- Accuray Incorporated
Madison, WI, US - Received
- September 2, 2021
- Decision date
- September 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Accuray Precision Treatment Planning System cleared by the FDA?
Accuray Precision Treatment Planning System (K212794) received a 510(k) decision of Substantially Equivalent on September 30, 2021, 28 days after the submission was received.
What is the product code of K212794?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.