EHD
- 产品代码
- EHD
- 器械名称
- Unit, X-Ray, Extraoral With Timer
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 872.1800
- FDA 专业组
- Dental
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 190 件
该代码近三年的 510(k)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260367 | 2026-05-27 | PDX Co., Ltd. | Portable Dental X-ray System Model PDX nova | FDA |
| K253864 | 2026-03-20 | Dental Imaging Technologies Corporatio | NOMAD Pro 3 | |
| K252110 | 2026-03-12 | Guangzhou Ajax Medical Equipment Co., | Dental X-RAY Unit (AJX200) | |
| K254018 | 2026-02-19 | Guilin Refine Medical Instrument Co., | Portable Dental X-ray Device (GT-1) | |
| K252909 | 2026-02-03 | Ningbo Runyes Medical Instrument Co., | Diagnostic X-Ray Equipment Model POCT22 | |
| K251438 | 2025-09-04 | Guilin Woodpecker Medical Instrument C | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master | |
| K242185 | 2024-12-04 | Raypia Co., Ltd. | Rextar Pro | |
| K242591 | 2024-11-01 | DRTECH Corporation | XERO-alpha | |
| K241963 | 2024-07-30 | Picopack Co., Ltd. | WERAY | FDA |
| K241305 | 2024-07-05 | Lucas Lifecare | LifeRay Intraoral Handheld X-ray System | FDA |
| K240759 | 2024-05-13 | Remedi Co., Ltd. | REMEX-GR100 | — |
| K233914 | 2024-02-08 | Shenzhen Xpectvision Technology Co., L | XVbeam2000 | |
| K233395 | 2024-01-03 | Alliage S/A Industrias Médico Odontoló | Portable Dental X-Ray (AXR60 S); Portable Dental X- | FDA |
| K231055 | 2023-12-28 | De Götzen S.R.L. | x-mind dc (under trademark Acteon), Owandy-RX DC (un | |
| K232085 | 2023-12-08 | Genoray Co., Ltd. | DVAS (DVAS-M, DVAS-W) | |
| K232012 | 2023-11-28 | Osstem Implant Co., Ltd. | N1 |
FDA 官方分类页： EHD
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。