510(k) K214084
K214084 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS". The FDA issued a decision of Substantially Equivalent on January 20, 2022. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Cefla S.C. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2022
- Date Received
- December 27, 2021
- 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.