Cyberknife System
FDA 510(k) K011024 · Accuray, Inc.
510(k) numberK011024
Submission
- Device name
- Cyberknife System
- Applicant
- Accuray, Inc.
Sunnyvale, CA, US - Received
- April 4, 2001
- Decision date
- August 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cyberknife System cleared by the FDA?
Cyberknife System (K011024) received a 510(k) decision of Substantially Equivalent on August 10, 2001, 128 days after the submission was received.
What is the product code of K011024?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.