MOS
- 产品代码
- MOS
- 器械名称
- Coil, Magnetic Resonance, Specialty
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1000
- 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)
- 490 件
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 |
|---|---|---|---|
| K262330 | 2026-07-30 | Philips Medical Systems Nederland B.V. | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1 摘要 |
| K262294 | 2026-07-24 | Philips Medical Systems Nederland B.V. | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiR 摘要 |
| K260947 | 2026-04-23 | Neocoil, LLC | 0.55T 12Ch Breast Coil 摘要 |
| K252587 | 2026-04-14 | Shenzhen RF Tech Co., Ltd. | HD 8Ch Wrist Array 摘要 |
| K252876 | 2026-04-01 | Shenzhen RF Tech Co., Ltd. | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Fle 摘要 |
| K260519 | 2026-03-20 | Philips Healthcare (Suzhou) Co., Ltd. | Smart Fit TorsoCardiac 1.5T 摘要 |
| K252179 | 2026-02-10 | Shenzhen RF Tech Co., Ltd. | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Fle 摘要 |
| K253738 | 2026-01-23 | Ge Healthcare Coils (Usa Instruments, | 3.0T AIR 32CH HNA 摘要 |
| K254190 | 2026-01-14 | Philips Medical Systems Nederland B.V. | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3. 摘要 |
| K253182 | 2025-10-20 | Inkspace Imaging, Inc. | InkSpace Imaging Small Body Array (SBA12PH30x) 摘要 |
| K243428 | 2025-07-17 | Dxtx Medical, Inc. | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0 摘要 |
| K244054 | 2025-02-28 | Quality Electrodynamics | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex 摘要 |
| K243675 | 2024-12-20 | Inkspace Imaging, Inc. | InkSpace Imaging Small Body Array 摘要 |
| K243316 | 2024-11-19 | Polarean, Inc. | XENOVIEW 3.0T Chest Coil 摘要 |
| K242879 | 2024-10-18 | Philips Medical Systems Nederland B.V. | dS Knee Coil 8ch 1.5T 摘要 |
| K243033 | 2024-10-18 | Philips Medical Systems Nederland B.V. | dS Wrist coil 8ch 1.5T 摘要 |
| K242096 | 2024-08-12 | Philips Medical Systems Nederland B.V. | dS FootAnkle Coil 8ch 1.5T 摘要 |
| K241069 | 2024-06-07 | Noras Mri Products GmbH | iLoop Interventional Coil 0.55T 摘要 |
| K233652 | 2024-02-16 | Quality Electrodynamics | Contour Hand/Wrist (Q7000232) 摘要 |
| K233656 | 2024-02-15 | Quality Electrodynamics | Contour Shoulder 摘要 |
| K233600 | 2024-02-05 | Philips Healthcare (Suzhou) Co., Ltd. | Smart Fit Knee 3.0T 摘要 |
| K233444 | 2024-01-08 | Inkspace Imaging, Inc. | InkSpace Imaging Small Body Array 摘要 |
| K233348 | 2023-10-24 | Philips Medical System Nederlands B.V. | 16 Breast Coil 摘要 |
| K232762 | 2023-10-03 | Invivo Corporation (Business Trade Nam | dS Breast Coil 7ch 1.5T 摘要 |
FDA 官方分类页： MOS
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。