Exactrac Robotics Novalis Robotics
FDA 510(k) K120520 · Brainlab AG
510(k) numberK120520
Submission
- Device name
- Exactrac Robotics Novalis Robotics
- Applicant
- Brainlab AG
Feldkirchen, DE - Received
- February 21, 2012
- Decision date
- June 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 Exactrac Robotics Novalis Robotics cleared by the FDA?
Exactrac Robotics Novalis Robotics (K120520) received a 510(k) decision of Substantially Equivalent on June 29, 2012, 129 days after the submission was received.
What is the product code of K120520?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.