510(k) K053558
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2006
- Date Received
- December 21, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type