FDA 510(k) clearance posted for Fussen Technology dental computed tomography X-ray systems

FDA 510(k) clearance record posted for Fussen Technology dental computed tomography X-ray systems (Rubik XSmart, Rubik X1, Rubik X3; Matrix 7000, Matrix 7800), product code OAS.

• The cleared device family includes Rubik XSmart, Rubik X1, Rubik X3 and Matrix 7000, Matrix 7800.
• Applicant is Fussen Technology Co., Ltd.; FDA review committee was Radiology.
• FDA product code is OAS under the 510(k) pathway.

Automated summary

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