510(k) K120520
K120520 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "EXACTRAC ROBOTICS NOVALIS ROBOTICS". The FDA issued a decision of Substantially Equivalent on June 29, 2012. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Brainlab AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2012
- Date Received
- February 21, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Couch, Radiation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 892.5770
- Review Panel
- RA
- Submission Type