510(k) K092547
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2009
- Date Received
- August 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type