510(k) K170502
K170502 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 April 13, 2017. 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
- April 13, 2017
- Date Received
- February 21, 2017
- Clearance Type
- Special
- 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