JAQ
- 产品代码
- JAQ
- 器械名称
- System, Applicator, Radionuclide, Remote-Controlled
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.5700
- 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)
- 18 件
- 其中 Summary 已存档
- 15 份，可直接下载
- FDA 历史累计 510(k)
- 208 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（18 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K262383 | 2026-07-24 | Nucletron B.V. | LumenCare Azure | |
| K252717 | 2026-05-20 | Varian Medical Systems | MAASTRO Rectal Applicator Set | FDA |
| K251037 | 2025-12-19 | Nucletron B.V. | Rectal Applicator | |
| K252884 | 2025-11-19 | Varian Medical Systems | Guided Aarhus Applicator Set | |
| K250299 | 2025-05-09 | Varian Medical Systems, Inc. | CT/ MR Tandem and Ovoid Set | |
| K250289 | 2025-04-25 | Varian Medical Systems | Intracavitary/Interstitial System | FDA |
| K243939 | 2025-03-03 | Varian Medical Systems, Inc. | Titanium Flexible Geometry FSD Applicator Set (GM110… | |
| K241764 | 2025-01-10 | Varian Medical Systems, Inc. | Mould Probe MR Safe | FDA |
| K242961 | 2024-11-26 | Varian Medical Systems | Intraluminal Applicator Set | |
| K243045 | 2024-11-19 | Braxx Biotech Co., Ltd. | BRAXX Esophageal Brachytherapy Applicator (Model: … | |
| K241853 | 2024-11-07 | Varian Medical Systems, Inc. | Titanium Fletcher-Style Applicator Set Defined Geome… | |
| K241965 | 2024-10-29 | Varian Medical Systems | Catheter Surface Flap Applicator Set (GM11011830) | |
| K241386 | 2024-08-30 | Varian Medical Systems, Inc. | Heyman Packing Applicator Set (GM11004580) | |
| K233628 | 2024-07-10 | Alpha-Omega Services, Inc. | AOS Interstitial Templates, Needles, and Accessories | |
| K233626 | 2024-07-02 | Alpha-Omega Services, Inc. | AOS Marker Seeds (SMG0242-025) | |
| K240495 | 2024-05-09 | Varian Medical Systems, Inc. | Flexible Fixation Device for Gynecological Applicato… | |
| K232623 | 2024-04-09 | Varian Medical Systems, Inc. | Universal Endometrial Applicator Set (GM11009840) | |
| K232949 | 2024-02-01 | Varian Medical Systems, Inc. | Kelowna GYN and Crook Prostate Templates |
FDA 官方分类页： JAQ
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。