KPR
- 产品代码
- KPR
- 器械名称
- System, X-Ray, Stationary
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1680
- 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)
- 357 件
该代码近三年的 510(k)（29 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260481 | 2026-08-27 | Samsung Electronics Co., Ltd. | GC85A | |
| K260482 | 2026-06-15 | Jpi Healthcare Co, Ltd. | DRE Duo | |
| K253446 | 2026-04-10 | Dk Medical Systems Co., Ltd. | AeroDR TX c02 | FDA |
| K250954 | 2026-01-20 | Carestream Health | DRX-Evolution Plus X-ray System, DRX-Compass Mobile | |
| K252000 | 2025-11-26 | Shanghai United Imaging Healthcare Co. | uDR Arria & uDR Aris | FDA |
| K251167 | 2025-09-19 | Shanghai United Imaging Healthcare Co. | uDR Aurora CX | |
| K250788 | 2025-08-28 | Ge Hualun Medical Systems Co. , Ltd. | Definium Tempo Select | |
| K250790 | 2025-08-01 | Dk Medical Systems Co., Ltd. | INNOVISION-DXII | FDA |
| K250738 | 2025-07-31 | Siemens Medical Solutions | YSIO X.pree | |
| K242019 | 2025-01-07 | DRGEM Corporation | GXR-Series Diagnostic X-Ray System | |
| K242499 | 2025-01-06 | Shenzhen Sontu Medical Imaging Equipme | Digital Radiography X-ray System (SONTU100-RAD (E) , | |
| K242119 | 2025-01-03 | Dk Medical System | INNOVISION-EXII | |
| K241068 | 2024-11-01 | Shanghai United Imaging Healthcare Co. | uDR 780i | |
| K242847 | 2024-10-23 | DRTECH Corporation | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS | |
| K242678 | 2024-10-01 | Ge Hualun Medical Systems Co. , Ltd. | Definium Pace Select ET | |
| K242478 | 2024-09-19 | Samsung Electronics Co., Ltd. | GF85 (models GF85-3P, GF85-SP) | |
| K233920 | 2024-08-06 | Eos Imaging | EOSedge | |
| K233530 | 2024-07-26 | DRTECH Corporation | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS | |
| K233662 | 2024-06-13 | Philips Medical Systems Dmc GmbH | Radiography 7300 C | |
| K233543 | 2024-05-21 | Siemens Medical Solutions | YSIO X.pree | |
| K233719 | 2024-03-28 | Shimadzu Corporation | FDR Visionary Suite | |
| K233381 | 2024-03-12 | Carestream Health, Inc. | DRX-Evolution Plus System | |
| K233722 | 2024-02-23 | Shimadzu Corporation | RADspeed Pro | |
| K233532 | 2023-11-29 | Siemens Medical Solutions | MULTIX Impact E | |
| K230800 | 2023-11-02 | GEMSS HEALTHCARE CO., LTD. | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, | |
| K231761 | 2023-10-27 | Skanray Technologies Limited | PodSKAN HF Diagnostic X-ray System | |
| K231995 | 2023-10-25 | Radmedix, LLC | AcuityUDR | |
| K232178 | 2023-09-19 | DRGEM Corporation | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES s | |
| K231892 | 2023-09-12 | Ge Hualun Medical Systems Co. , Ltd. | Definium Pace Select |
FDA 官方分类页： KPR
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。