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510(k) clearances

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)

Fussen Technology Co., Ltd. · Radiology

K263033Substantially EquivalentSpecialOAS
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Radiology
Address 1
901,1001, Bldg. #D1, Nanshan Zhiyuan, 1001 Xueyuan Ave., Cha
Statement or summary
Summary
Product code
OAS
Zip code
518055
Applicant
Fussen Technology Co., Ltd.
Decision date
2026-09-30
Decision code
SESE
Country code
CN
Device name
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Advisory committee
RA
Contact
Guiqin Zheng
K number
K263033
Date received
2026-08-31
Review advisory committee
RA
Postal code
518055
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
X-Ray, Tomography, Computed, Dental
Medical specialty description
Radiology
Regulation number
892.1750
Device class
2
Registration number
3012649815, 3045816948, 3010445368, 3009196578, 3005554774, 3031093388, 3004706313, 3014398772, 3009543051, 3012957335, 2024980, 3004884150, 9614977, 3010281549, 9615832, 8043728, 3005383085, 3030898585, 3013510497, 3013511605, 3023322470, 3045129740, 3030089802, 3001052305, 3016875543, 3002807636, 3012494290, 8030876, 1226003, 3005843418, 3003528079, 3015509619, 3021551875, 3031886796, 3002994636, 3005706667, 3011471624, 3018596740, 3006610845, 3009717300 +8 more
FEI number
3012649815, 3045816948, 3010445368, 3008875470, 3009196578, 3005554774, 3031093388, 3002807903, 3004706313, 3014398772, 3009543051, 3012957335, 3004884150, 3010281549, 3002522649, 3005383085, 3030898585, 3013510497, 3013511605, 3023322470, 3003719498, 3045129740, 3030089802, 3001052305, 3016875543, 3002807636, 3012494290, 3005843418, 3003528079, 3015509619, 3021551875, 3031886796, 3002994636, 3005706667, 1000207287, 3011471624, 3003026827, 3006610845, 3009717300, 3018596740 +8 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.