Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)— 510(k) K263033
Substantially EquivalentFussen Technology Co., Ltd.
FDA 510(k) clearance K263033 for Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800), Substantially Equivalent on 2026-09-30. Applicant: Fussen Technology Co., Ltd.. Device class: 2.
Summary
Fussen Technology Co., Ltd. cleared several dental CT models in one file: Rubik XSmart, Rubik X1, Rubik X3, Matrix 7000, and Matrix 7800. The product code is OAS, dental computed tomography X-ray systems.
Class II, 21 CFR 892.1750. The Radiology panel reviewed it. Fussen filed it as a Special 510(k).
Fussen is in Shenzhen, China. The clock ran 30 days (August 31 to September 30, 2026).
Clearance details
- Applicant
- Fussen Technology Co., Ltd.
- Product code
- Product code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shenzhen, CN
Recent devices under product code OAS
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