OAS
- 产品代码
- OAS
- 器械名称
- X-Ray, Tomography, Computed, Dental
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 892.1750
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 24 件
- 其中 Summary 已存档
- 22 份,可直接下载
- FDA 历史累计 510(k)
- 135 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
该代码近三年的 510(k)(24 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页: OAS
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。