FET
- 产品代码
- FET
- 器械名称
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.1500
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 100 件
FDA 分类定义
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
该代码近三年的 510(k)（10 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261880 | 2026-07-02 | Fujifilm Corporation | FUJIFILM Processor EP-8000;Balloon Controller PB-30; 摘要 |
| K261260 | 2026-06-24 | Olympus Medical Systems Corporation | HD Camera Head OLYMPUS CH-S200-08-LB 摘要 |
| K251734 | 2025-09-24 | Proverum Limited | ProVee Video Processing Unit (PV-003) 摘要 |
| K250462 | 2025-08-11 | Univlabs Technologies Private Limited | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) 摘要 |
| K250204 | 2025-07-01 | Shenzhen Sophway Technology Co., Ltd. | Endoscopic Camera System 摘要 |
| K243260 | 2025-04-11 | Fujifilm Corporation | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model 摘要 |
| K242067 | 2025-04-02 | Olympus Corporations of the Americas | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S70 摘要 |
| K243321 | 2025-02-07 | Guangzhou Red Pine Medical Instrument | Endoscopic Video Image Processor (RP-IPD-V1000F) 摘要 |
| K241532 | 2024-10-22 | Shanghai SeeGen Photoelectric Technolo | Flexible Video-Choledo-Cysto-Ureteroscope System (PL 摘要 |
| K241371 | 2024-07-03 | Olympus Medical Systems Corporation | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMP 摘要 |
FDA 官方分类页： FET
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。