510(k) K263033
- Device
- Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
- Applicant
- Fussen Technology Co., Ltd.
- 510(k) number
- K263033
- Product code
- OAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-30
- Date received
- 2026-08-31
- Regulation
- 892.1750
- Classification name
- X-Ray, Tomography, Computed, Dental
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Guiqin Zheng
- Address
- 901,1001, Bldg. #D1, Nanshan Zhiyuan, 1001 Xueyuan Ave., Cha Shenzhen CN 518055 518055
FDA Registration Numbers#
- 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
- 8020825
- 3035879459
- 3002819275
- 3018999255
- 3009715136
- 3008770655
- 3017403245
- 3007538876
Source Documents#
Other 510(k) Records For Product Code OAS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 |
| K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 |
| K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2026-06-04 |
| K253935 | medXion NEXUS | medXion Technologies, Inc. | 2026-05-15 |
| K260462 | RCT800 | Ray Co., Ltd. | 2026-04-09 |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | 2026-03-31 |
| K252353 | myray ProXIma X6 | Cefla S.C. | 2026-03-10 |
| K251798 | RCT700 | Ray Co., Ltd. | 2025-11-25 |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025-11-13 |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025-10-08 |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2025-04-17 |
| K243903 | RCT600 | Ray Co., Ltd. | 2025-03-12 |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | 2025-02-21 |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | 2025-02-14 |