510(k) clearance
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
- 510(k) number
- K263033
- Applicant
- Fussen Technology Co., Ltd.
- Decision date
- Sep 30, 2026
- Date received
- Aug 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- OAS
- Device type
- X-Ray, Tomography, Computed, Dental
- Device class
- Class II
- Regulation
- 21 CFR 892.1750
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN