OAS · X-Ray, Tomography, Computed, Dental
Radiology · 21 CFR 892.1750 · Class 2
Overview
| Product Code | OAS |
|---|---|
| Device Name | X-Ray, Tomography, Computed, Dental |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 131)
Showing 20 most recent of 131 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260462 | RCT800 | Ray Co., Ltd. | Apr 9, 2026 | SESE |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | Mar 31, 2026 | SESE |
| K252353 | myray ProXIma X6 | Cefla S.C. | Mar 10, 2026 | SESE |
| K253959 | Primevision 3D | Dentsply Sirona | Feb 5, 2026 | SESE |
| K251798 | RCT700 | Ray Co., Ltd. | Nov 25, 2025 | SESE |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | Nov 13, 2025 | SESE |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | Oct 8, 2025 | SESE |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | Jun 27, 2025 | SESE |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | Apr 17, 2025 | SESE |
| K243903 | RCT600 | Ray Co., Ltd. | Mar 12, 2025 | SESE |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | Feb 21, 2025 | SESE |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | Feb 14, 2025 | SESE |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | Jan 9, 2025 | SESE |
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Palodex Group OY | Sep 12, 2024 | SESE |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | Sep 6, 2024 | SESE |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | Apr 25, 2024 | SESE |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | Jan 9, 2024 | SESE |
| K230985 | Planmeca Viso | Planmeca Oy | Dec 28, 2023 | SESE |
| K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | Dec 14, 2023 | SESE |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | Sep 14, 2023 | SESE |
Top Applicants
- VATECH Co., Ltd. — 19 clearances
- Ray Co., Ltd. — 15 clearances
- Prexion Corporation — 9 clearances
- Palodex Group OY — 8 clearances
- Cefla S.C. — 7 clearances
