OAS
- Product code
- OAS
- Device name
- X-Ray, Tomography, Computed, Dental
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1750
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 24
- Summaries archived here
- 22 (direct download)
- 510(k) clearances (all years, FDA)
- 135 (all years; only the last 3 years are listed here)
FDA classification definition
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261748 | 2026-07-23 | Hefei Meyer Optoelectronic Technology,… | Dental Cone-beam Computed Tomography (mDX-15P Series… | |
| K250839 | 2026-06-11 | Changzhou Boen Zhongding Medical Techn… | Dental X-ray System | |
| K260662 | 2026-06-04 | Yofo Medical Technology Co., Ltd. | Dental Cone Beam Computed Tomography System | |
| K253935 | 2026-05-15 | medXion Technologies, Inc. | medXion NEXUS | |
| K260462 | 2026-04-09 | Ray Co., Ltd. | RCT800 | |
| K260093 | 2026-03-31 | VATECH Co., Ltd. | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | |
| K252353 | 2026-03-10 | Cefla S.C. | myray ProXIma X6 | |
| K253959 | 2026-02-05 | Dentsply Sirona | Primevision 3D | |
| K251798 | 2025-11-25 | Ray Co., Ltd. | RCT700 | |
| K251842 | 2025-11-13 | Fussen Technology Co., Ltd. | Dental Computed Tomography X-ray System | |
| K250060 | 2025-10-08 | Genoray Co., Ltd. | GT300; GT300-C | |
| K251642 | 2025-06-27 | Yian Medical Technology (Haining) Co.,… | Dental CBCT X-ray System | |
| K243337 | 2025-04-17 | Yofo Medical Technology Co., Ltd. | Dental Cone Beam Computed Tomography System | |
| K243903 | 2025-03-12 | Ray Co., Ltd. | RCT600 | |
| K243088 | 2025-02-21 | VATECH Co., Ltd. | Green X 12 SE (PHT-40CHS) | |
| K243081 | 2025-02-14 | VATECH Co., Ltd. | Green X 21 (PHT-90CHO) | |
| K242805 | 2025-01-09 | Changzhou Finno Medical Technology Co.… | Dental Cone-beam Computed Tomography (FinScan F350) | |
| K241249 | 2024-09-12 | Palodex Group OY | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomogr… | |
| K233806 | 2024-09-06 | Osstem Implant Co., Ltd. | T2 Plus | |
| K240855 | 2024-04-25 | Yian Medical Technology (Haining) Co.,… | Dental Cone-beam Computed Tomography | |
| K232710 | 2024-01-09 | Yian Medical Technology (Haining) Co.,… | Dental Cone-beam Computed Tomography | FDA |
| K230985 | 2023-12-28 | Planmeca Oy | Planmeca Viso | |
| K231181 | 2023-12-14 | Dentium Co., Ltd (Ict Branch) | bright CT | FDA |
| K232487 | 2023-09-14 | Durr Dental SE | Provecta 3D Prime and Provecta 3D Prime Ceph |
Official FDA classification page: OAS
Classification and pathway per current FDA publications. Data from openFDA (CC0).