Cyberknife Robotic Radiosurgery System
FDA 510(k) K062514 · Accuray Incorporated
510(k) numberK062514
Submission
- Device name
- Cyberknife Robotic Radiosurgery System
- Applicant
- Accuray Incorporated
Sunnyvale, CA, US - Received
- August 28, 2006
- Decision date
- September 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K161146 | Radixact Treatment Delivery SystemIYE · Traditional | 06/24/2016SE |
| K161144 | iDMS Data Management SystemIYE · Traditional | 06/24/2016SE |
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Questions and answers
When was Cyberknife Robotic Radiosurgery System cleared by the FDA?
Cyberknife Robotic Radiosurgery System (K062514) received a 510(k) decision of Substantially Equivalent on September 28, 2006, 31 days after the submission was received.
What is the product code of K062514?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.