ITX
- 产品代码
- ITX
- 器械名称
- Transducer, Ultrasonic, Diagnostic
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1570
- FDA 专业组
- Radiology
- 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)
- 414 件
该代码近三年的 510(k)（15 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261170 | 2026-08-12 | Fujifilm Corporation | BA-004CC | |
| K254143 | 2026-08-10 | EM-TECH Solutions, Inc. | EM-TECH Passive Ultrasound Probe Strap | |
| K260161 | 2026-07-30 | UC-CARE , Ltd. | SmartGuide Disposable Guides and Grids | |
| K262474 | 2026-07-27 | Accurate Access, LLC | ND Needle Guidance System | |
| K261014 | 2026-07-24 | Rivanna Medical, Inc. | Accuro® 3S Needle Guide Kit | |
| K250883 | 2025-09-18 | Olympus Medical Systems Corporation | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM- | |
| K250762 | 2025-07-11 | Olympus Medical Systems Corporation | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC | |
| K250524 | 2025-07-02 | Mendaera, Inc. | Mendaera Guidance System | |
| K250469 | 2025-06-13 | Rivanna Medical, Inc. | Accuro® 3S Needle Guide Kit | |
| K241662 | 2024-08-30 | Vitrolife Sweden AB | Ultrasound Transducer Cover | |
| K233965 | 2024-08-15 | Parker Laboratories, Inc. | UltraDrape UGPIV Barrier and Securement (34-15) | |
| K241615 | 2024-07-03 | Hony Medical Co., Ltd. | Transducer Probe Cover | |
| K233109 | 2023-12-22 | Civco Medical Solutions | TP Pivot Pro Needle Guide | |
| K231666 | 2023-12-13 | FUJIFILM Healthcare Americas Corporati | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic | |
| K231783 | 2023-11-14 | CIVCO Medical Instruments Co., Inc. | VitroPRO | FDA |
FDA 官方分类页： ITX
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。