510(k) K253935
- Device
- medXion NEXUS
- Applicant
- medXion Technologies, Inc.
- 510(k) number
- K253935
- Product code
- OAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-15
- Date received
- 2025-12-09
- Regulation
- 892.1750
- Classification name
- X-Ray, Tomography, Computed, Dental
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kazuhito Tomii
- Address
- 2-12-27 Kodo Adachi-Ku Tokyo JP 1200013 1200013
FDA Registration Numbers#
- 3005554774
- 3015509619
- 3023322470
- 3014398772
- 3005843418
- 3013511605
- 3003528079
- 3021551875
- 3014980469
- 3004706313
- 3004884150
- 3030898585
- 3018596740
- 8043728
- 3009717300
- 3002807636
- 3009715136
- 3016875543
- 3012957335
- 9614977
- 3017403245
- 3002819275
- 3011471624
- 1226003
- 3009543051
- 3012649815
- 3005383085
- 3031886796
- 2024980
- 3010281549
- 8030876
- 3006610845
- 3002994636
- 8020825
- 3005706667
- 3010445368
- 3009196578
- 3001052305
- 3012494290
- 3007538876
- 3035879459
- 3030089802
- 3018999255
- 3031093388
- 3008770655
- 9615832
Source Documents#
Other 510(k) Records For Product Code OAS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253959 | Primevision 3D | Dentsply Sirona | 2026-02-05 |
| 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 |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | 2025-01-09 |
| K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) | Palodex Group OY | 2024-09-12 |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | 2024-09-06 |