Cleared Special

K263033 - Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)

K263033 is an FDA 510(k) clearance for Dental Computed Tomography X-ray System..., manufactured by Fussen Technology Co., Ltd.. The device is a Class 2 Radiology device with product code OAS cleared through the Special 510(k) pathway after a 30-day FDA review.

K263033 · Fussen Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
30d
Days
Class 2
Risk

K263033 is an FDA 510(k) clearance for the Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (M.... Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Fussen Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 30, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fussen Technology Co., Ltd. devices

FDA 510(k) Submission Details - K263033

510(k) Number K263033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2026
Decision Date September 30, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 134
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K263033.
Dental Cone-beam Computed Tomography (mDX-15P Series)
K261748 · Hefei Meyer Optoelectronic Technology, Inc. · Jul 2026
Dental X-ray System
K250839 · Changzhou Boen Zhongding Medical Technology Co., Ltd. · Jun 2026
Dental Cone Beam Computed Tomography System
K260662 · Yofo Medical Technology Co., Ltd. · Jun 2026
medXion NEXUS
K253935 · medXion Technologies, Inc. · May 2026
RCT800
K260462 · Ray Co., Ltd. · Apr 2026
myray ProXIma X6
K252353 · Cefla S.C. · Mar 2026