MQB
- 产品代码
- MQB
- 器械名称
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- 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)
- 424 件
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253800 | 2026-07-31 | Rayence Co., Ltd. | 0909FCE, 0909FCE-HS 摘要 |
| K260820 | 2026-06-18 | Vieworks Co., Ltd. | VIVIX-S 4386W (FXRD-4386WA) 摘要 |
| K252996 | 2026-06-12 | Konica Minolta Healthcare Americas, In | Universal 1417PI 摘要 |
| K252911 | 2025-10-09 | Iray Imaging Technology (Haining) Limi | Lux HD 2530 detector (Lux HD 2530) 摘要 |
| K250211 | 2025-07-22 | Innocare Optoelectronics Corp. | Yushan X-Ray Flat Panel Detector 摘要 |
| K250665 | 2025-06-17 | Konica Minolta, Inc. | SKR 3000 摘要 |
| K243734 | 2025-04-18 | Allengers Medical Systems Limited | Wireless/ Wired X-Ray Flat Panel Detectors 摘要 |
| K242770 | 2025-03-20 | DRTECH Corporation | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG 摘要 |
| K243443 | 2025-03-19 | DRTECH Corporation | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; E 摘要 |
| K243556 | 2025-03-18 | Iray Imaging Technology (Haining) Limi | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector ( 摘要 |
| K244010 | 2025-02-24 | Jpi Healthcare Co, Ltd. | ExamVue Apex 摘要 |
| K243171 | 2024-12-19 | Innocare Optoelectronics Corp. | Yushan X-Ray Flat Panel Detector 摘要 |
| K241319 | 2024-11-21 | Konica Minolta, Inc. | SKR 3000 摘要 |
| K241125 | 2024-11-15 | Vieworks Co., Ltd. | VIVIX-S 1751S 摘要 |
| K240771 | 2024-11-12 | Prognosys Medical Systems Private Limi | PRORAD X-Ray Flat Panel Detector with DROC 摘要 |
| K241346 | 2024-11-07 | Aspen Imaging Healthcare, Inc. | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Pan 摘要 |
| K242394 | 2024-09-09 | Rayence Co., Ltd. | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE- 摘要 |
| K240371 | 2024-03-07 | Rayence Co., Ltd. | 0909FCC, 0909FCC-HS 摘要 |
| K232082 | 2024-02-13 | DRTECH Corporation | EXPD 4343S 摘要 |
| K232753 | 2023-11-16 | DRTECH Corporation | EXPD 4343D; EXPD 3643D 摘要 |
FDA 官方分类页： MQB
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。