510(k) K263033
K263033 is an FDA 510(k) premarket notification submitted by Fussen Technology Co., Ltd. for the device "Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)". The FDA issued a decision of Substantially Equivalent on Sep 30, 2026. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Fussen Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2026
- Date Received
- Aug 31, 2026
- 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
- 510(k)
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.