510(k) K130297
K130297 is an FDA 510(k) premarket notification submitted by Palodex Group OY for the device "SCANORA 3DX". The FDA issued a decision of Substantially Equivalent on May 29, 2013. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Palodex Group OY has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2013
- Date Received
- February 6, 2013
- Clearance Type
- Special
- 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.