510(k) K150354
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2015
- Date Received
- February 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- X-Ray, Tomography, Computed, Dental
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.