IZL
- 产品代码
- IZL
- 器械名称
- System, X-Ray, Mobile
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1720
- 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)
- 237 件
该代码近三年的 510(k)（25 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260236 | 2026-08-03 | GEMSS HEALTHCARE CO., LTD. | XLITE 摘要 |
| K253058 | 2026-06-18 | Shantou Institute of Ultrasonic Instru | Portable DR Imaging System 摘要 |
| K260085 | 2026-05-14 | DRGEM Corporation | RAYMO Mobile X-ray System (Model: RAYMO) 摘要 |
| K253185 | 2026-03-11 | Carestream Health | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mo 摘要 |
| K253244 | 2026-02-23 | Poskom Co., Ltd. | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, A 摘要 |
| K250976 | 2025-12-19 | Poskom Co., Ltd. | Airbile-100 摘要 |
| K251710 | 2025-10-24 | Solutions For Tomorrow AB | Mobile X-ray unit (!M1) 摘要 |
| K243864 | 2025-09-12 | Bontech Co., Ltd. | BONX805 摘要 |
| K251443 | 2025-08-22 | DRGEM Corporation | PROMO 摘要 |
| K251223 | 2025-08-04 | H&abyz Co., Ltd. | HnX-P1, HnX-PB 摘要 |
| K250597 | 2025-07-31 | Remedi, Inc. | REMEX Xcam6 摘要 |
| K243473 | 2025-07-29 | Prognosys Medical Systems Private Limi | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTAB 摘要 |
| K250750 | 2025-07-18 | Dk Medical Systems Co., Ltd. | INNOVISION-P5 摘要 |
| K244049 | 2025-05-28 | Livermoretech, Inc. | Europa (Alternative: AiRTouch) portable X-ray system 摘要 |
| K241980 | 2025-05-06 | Solutions For Tomorrow AB | !M1 摘要 |
| K241996 | 2025-04-18 | Ecoray Co., Ltd. | ULTRA 1040 摘要 |
| K242015 | 2024-12-16 | DRGEM Corporation | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ 摘要 |
| K241505 | 2024-12-10 | Carestream Health, Inc. | DRX-Revolution Mobile X-ray System 摘要 |
| K240841 | 2024-12-09 | Shenzhen Browiner Tech Co., Ltd. | Digital Radiography System (ManntiX B, ManntiX K) 摘要 |
| K242515 | 2024-10-10 | Shanghai United Imaging Healthcare Co. | uDR 380i Pro 摘要 |
| K242651 | 2024-10-01 | Samsung Electronics Co., Ltd. | GM85 摘要 |
| K234108 | 2024-09-20 | Energy Resources International Co., Lt | ERI Portable X-ray System (CVX-air); ERI Portable X- 摘要 |
| K240009 | 2024-07-03 | First Source, Inc. | iQFlex Pro 摘要 |
| K240284 | 2024-03-28 | Shenzhen Browiner Tech Co., Ltd. | Digital Radiography System (MobileApex 60E, MobileAp 摘要 |
| K233678 | 2024-02-14 | Philips Medical Systems Dmc GmbH | Radiography 7000 M 摘要 |
FDA 官方分类页： IZL
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。