Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Device Facts
| Record ID | K263033 |
|---|---|
| Device Name | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) |
| Applicant | Fussen Technology Co., Ltd. |
| Product Code | OAS · Radiology |
| Decision Date | Sep 30, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions. The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician.
Device Story
Dental Computed Tomography X-ray System (Matrix 7000, Matrix 7800) produces CBCT, panoramic, and cephalometric images; used in hospitals and clinics by trained professionals under physician guidance. System components include X-ray tube, flat panel detector, control device, positioning aids, and workstation software. Device captures X-ray projections; software processes data for image acquisition, viewing, and transmission. Output images assist clinicians in oral and maxillofacial diagnostics. System supports DICOM 3.0 connectivity.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including performance testing (IEC 61223-3-7, IEC 61223-3-4, IEC 60336, ISO 12052), biocompatibility (ISO 10993-1, -5, -10, -23), electrical safety/EMC (IEC 60601 series), and software/cybersecurity validation.
Technological Characteristics
X-ray generator (1.2kW, 60-120kV, 2-10mA); flat panel detector (100-125um pixel size); 0.5mm focal spot. Connectivity: DICOM 3.0. Software: DTKL workstation software for image management. Standards: IEC 60601-1, IEC 60601-2-63, ISO 10993, ISO 12052.
Indications for Use
Indicated for pediatric and adult patients requiring X-ray Cone-Beam Computed Tomography, Panoramic tomography, or Cephalometric imaging for diagnostic purposes in oral and maxillofacial regions.
Regulatory Classification
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (K251842)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
September 30, 2026
Fussen Technology Co., Ltd.
% Guiqin Zheng
regulatory affairs
901,1001, Bldg. #D1, Nanshan Zhiyuan, 1001 Xueyuan Ave., Changyuan Community, Taoyuan St.,
Nanshan District
SHENZHEN, GUANGDONG 518055
CHINA
Re: K263033
Trade/Device Name: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: OAS
Dated: August 31, 2026
Received: August 31, 2026
Dear Guiqin Zheng:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K263033 - Guiqin Zheng
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K263033 - Guiqin Zheng
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K263033 | ? |
| Please provide the device trade name(s). | | ? |
| Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | | |
| Please provide your Indications for Use below. | | ? |
| The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions.The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician. | | |
| Please select the types of uses. | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |
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# 510(k) Summary K263033
## I. Submitter
Fussen Technology Co., Ltd
901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District, 518055 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA
Contact person: Ms. Guiqin Zheng
Position: regulatory affairs
Tel.: 0086-15907673812
E-mail: venus.zheng@fussengroup.com
Preparation date: August 5, 2026
## II. Proposed Device
| Device Trade Name: | Dental Computed Tomography X-ray System(Rubik X1, Rubik X3) |
| --- | --- |
| Common name: | Computed tomography x-ray system. |
| Regulation Number: | 21 CFR 892.1750 |
| Regulatory Class: | Class II |
| Product code: | OAS |
| Review Panel: | Radiology |
| 510(k) number: | K263033 |
## III. Predicate Devices
510(k) Number: K251842
Trade name: Dental Computed Tomography X-ray System(Rubik X1, Rubik X3)
Common name: Computed tomography x-ray system.
Classification: Class II
Product Code: OAS
Manufacturer Fussen Technology Co., Ltd
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#### IV. Device description
The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions.
The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician.
This device is divided into two models: Matrix 7000, Matrix 7800.
This product is composed of X-ray tube, flat panel detector, control device, positioning aid, frame, cephalometric positioning shooting aid (Optional), workstation software, etc.
#### V. Indications for use
The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions.
The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician.
#### VI. Comparison of technological characteristics with the predicate devices
The comparison and discussion between the subject device and the predicate devices are listed in below table
Table 5.2-1 General Comparison
| Characteristics | Proposed device | Predicate device (K251842) | Discussion |
| --- | --- | --- | --- |
| Trade name | Dental Computed Tomography X-ray System(Rubik X1, Rubik X3) | Dental Computed Tomography X-ray System(Rubik XSmart, Rubik X1, Rubik X3) | / |
| Classification Name | Computed tomography x-ray system | Computed tomography x-ray system | Same |
| Product Code | OAS | OAS | Same |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
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| Characteristics | Proposed device | Predicate device (K251842) | Discussion |
| --- | --- | --- | --- |
| Indications for use | The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions. The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician. | The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions. The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician. | Same |
| Device Structure | This product is composed of X-ray tube, flat panel detector, control device, positioning aid, frame, cephalometric positioning shooting aid, workstation software, etc. | This product is composed of X-ray tube, flat panel detector, control device, positioning aid, frame, cephalometric positioning shooting aid (Optional), workstation software, etc. | Similar |
| Power supply | AC 120 V (US)/230 V (EU) V, 60Hz (US)/50 Hz (EU) | AC 120 V (US)/230 V (EU) V, 60Hz (US)/50 Hz (EU) | Same |
| Patient population | pediatric and adult patients | pediatric and adult patients | Same |
| Clinical conditions | The product is intended for use in hospitals and clinics. | The product is intended for use in hospitals and clinics. | Same |
| Dimension | 1650 (L) × 1840 (W) × 2250 (H) (mm) | 1650 (L) × 1840 (W) × 2250 (H) (mm) | Same |
| Tube voltage | 60-120kV | 60-120kV | Same |
| Tube current | 2-10mA | 2-10mA | Same |
| X-ray generator rated | 1.2kW | 1.2kW | Same |
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| Characteristics | | Proposed device | Predicate device (K251842) | Discussion |
| --- | --- | --- | --- | --- |
| output power | | | | |
| Focus nominal value | | 0.5 mm | 0.5 mm | Same |
| Voxel size (mm) | | 0.3-0.05 | 0.3-0.05 | Same |
| SID (Source Image Distance) | CT photography: 635mm | CT photography: 635mm | Same | |
| | | Panorama photography: 635mm | | Panorama photography: 635mm |
| | | Cephalometric photography: 1722mm | | Cephalometric photography: 1722mm |
| Active area & Pixel size | CT | 153.6*153.6mm, 100um(Matrix 7000); 204.8*204.8mm, 100um(Matrix 7800) | 153.6*153.6mm, 100um(Matrix 7000); 204.8*204.8mm, 100um(Matrix 7800) | Same |
| | PANO | 153.6*153.6mm, 100um(Matrix 7000); 204.8*204.8mm, 100um(Matrix 7800) | 153.6*153.6mm, 100um(Matrix 7000); 204.8*204.8mm, 100um(Matrix 7800) | |
| | CEPH | 225.2mm×6.8mm, 100um(Matrix 7000); 250mm×300mm, 125um(Matrix 7800) | 225.2mm×6.8mm, 100um(Matrix 7000); 250mm×300mm, 125um(Matrix 7800) | |
| FOV | | Matrix 7000: 16cm*16cm, 16cm*10cm, 12cm*10cm, 9cm*9cm, 8cm*9cm, 5cm*5cm; Matrix 7800: 18cm×20cm, 18cm×13cm, 16cm×11cm, 12cm×10cm, 9cm×9cm, | Matrix 7000 Configuration 1: 16cm*16cm, 16cm*10cm, 12cm*10cm, 9cm*9cm, 8cm*9cm, 5cm*5cm; Matrix 7000 Configuration 2: 16cm*16cm(Optional), 16cm*10cm, 12cm*10cm, 9cm*9cm, 8cm*9cm, 5cm*5cm; Matrix 7800: 18cm×20cm, 18cm×13cm, 16cm×11cm, 12cm×10cm, 9cm×9cm, 8cm×9cm, 5cm×5cm | Similar |
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| Characteristics | | Proposed device | Predicate device (K251842) | Discussion |
| --- | --- | --- | --- | --- |
| | | 8cm×9cm, 5cm×5cm | | |
| Scan time | | Max 30s(Matrix 7000); Max 24s(Matrix 7800) | Max 30s(Matrix 7000); Max 24s(Matrix 7800) | Same |
| Software | Compatibility | DICOM 3.0 format compatible | DICOM 3.0 format compatible | Same |
| | Name | DTKL | DTKL | |
| | Function | Patient information management, image acquisition, image viewing, transmission and output functions | Patient information management, image acquisition, image viewing, transmission and output functions | |
| 3D Scan mode | | √ | Matrix 7000 Configuration 1: √ Matrix 7000 Configuration 2: × Matrix 7800: √ | Similar |
### VII. Non-Clinical Testing
The devices described in this summary, were tested and demonstrated to be in conformance with the following standards:
**Performance testing :**
- IEC 61223-3-7
- IEC 61223-3-4
- IEC 60336
- ISO 12052
**Biocompatibility testing**
Biocompatibility of the device was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1" The following testing was conducted:
- ISO 10993-1
- ISO 10993-5
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ISO 10993-10
ISO 10993-23
# Software
Guidance for Industry and Food and Drug Administration Staff-Content of Premarket Submissions for Device Software Functions
# Cybersecurity
Guidance for Industry and Food and Drug Administration Staff-Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
# Electrical Safety and EMC
IEC 60601-1 /ANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-4-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-63
IEC 62366-1
# VIII. Clinical Testing
No clinical study is included in this submission.
# IX. Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.
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