510(k) K122413
K122413 is an FDA 510(k) premarket notification submitted by Forte Automation Systems, Inc. for the device "PATIENT POSITIONING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 13, 2012. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Forte Automation Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2012
- Date Received
- August 8, 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