IYO
- 产品代码
- IYO
- 器械名称
- System, Imaging, Pulsed Echo, Ultrasonic
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1560
- 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)
- 894 件
该代码近三年的 510(k)（30 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253452 | 2026-07-24 | Rivanna Medical, Inc. | Accuro 3S 摘要 |
| K260190 | 2026-06-18 | ROPCA ApS | ARTHUR 摘要 |
| K252237 | 2026-04-17 | Edgecare, Inc. | EdgeFlow UW20 摘要 |
| K254021 | 2026-04-09 | Rivanna Medical, Inc. | Accuro XV 摘要 |
| K253898 | 2026-03-04 | QT Imaging Holdings, Inc. | QT Scanner 2000 Model A 摘要 |
| K253714 | 2026-02-24 | Philips Image Guided Therapy Corporati | IntraSight Plus 摘要 |
| K253221 | 2026-02-06 | Eieling Technology (Shenzhen) Limited | Liver fat ultrasound quantitative system, The FattaL 摘要 |
| K250331 | 2025-09-30 | Astrasono Technology Co., Ltd. | Astrasono A3Pro Bladder Scanner (A3Pro) 摘要 |
| K250381 | 2025-08-01 | DeepSight Technology, Inc. | Deepsight NeedleVue LC1 Ultrasound System 摘要 |
| K243227 | 2025-07-11 | Accutome, Inc. Doing Business AS Keele | B-Scan 摘要 |
| K251728 | 2025-06-26 | Sonic Incytes Medical Corp | Velacur One (LI-1100) 摘要 |
| K243880 | 2025-06-17 | Wuxi Hisky Medical Technologies Co., L | Shear Wave Quantificational Ultrasound Diagnostic Sy 摘要 |
| K243937 | 2025-05-23 | Rivanna Medical, Inc. | Accuro 3S 摘要 |
| K243479 | 2025-04-23 | Sonavex, Inc. | EchoGuide (Version 1) 摘要 |
| K242496 | 2024-11-19 | Eieling Technology (Shenzhen) Limited | Portable Liver Elastography Ultrasound Diagnostic Sy 摘要 |
| K241029 | 2024-10-07 | Verdure Imaging | SpineUs System 摘要 |
| K233977 | 2024-09-04 | Sonic Incytes | Velacur 摘要 |
| K233579 | 2024-06-26 | Fcu Co., Ltd. | SC1 Handheld Ultrasound Imaging system (Model: SC1) 摘要 |
| K233613 | 2024-06-12 | Siemens Medical Solutions USA, Inc. | ACUSON SC2000 Diagnostic Ultrasound System 摘要 |
| K232895 | 2024-05-03 | Contec Medical Systems Co.,Ltd | B-Ultrasound Diagnostic System 摘要 |
| K232302 | 2024-04-26 | Quantel Medical | Pocket III 摘要 |
| K231677 | 2024-03-06 | Edgecare, Inc. | EdgeFlow UH10 摘要 |
| K240146 | 2024-02-18 | Bard Access Systems, Inc. | BD Prevue II Peripheral Vascular Access System 摘要 |
| K233401 | 2024-02-12 | Eieling Technology Limited | Portable Liver Elastography Ultrasound Diagnostic Sy 摘要 |
| K230986 | 2023-12-29 | Avantsonic Technology Co., Ltd. | Bladder Scanner 摘要 |
| K232320 | 2023-12-21 | Biobot Surgical Pte., Ltd. | iSR`obot Mona Lisa 2.0 摘要 |
| K231889 | 2023-12-21 | Ultrasound Biotechnology (Shanghai) Co | Endoscopic Ultrasonic Diagnostic Equipment /Disposab 摘要 |
| K230511 | 2023-10-25 | Maui Imaging | K3900 Ultrasound Imaging System 摘要 |
| K232459 | 2023-09-12 | Sonic Incytes | Velacur 摘要 |
| K231283 | 2023-09-11 | Bard Access Systems, Inc. (C.R. Bard, | SiteRite 9 Ultrasound System 摘要 |
FDA 官方分类页： IYO
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。