510(k) K161937
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2016
- Date Received
- July 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type