510(k) K200688
K200688 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "hyperion X5, NewTom GO, X-RADiUS COMPACT". The FDA issued a decision of Substantially Equivalent on April 9, 2020. 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
- April 9, 2020
- Date Received
- March 16, 2020
- 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.