MQB
- Product code
- MQB
- Device name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1680
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 20
- Summaries archived here
- 18 (direct download)
- 510(k) clearances (all years, FDA)
- 424 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253800 | 2026-07-31 | Rayence Co., Ltd. | 0909FCE, 0909FCE-HS | |
| K260820 | 2026-06-18 | Vieworks Co., Ltd. | VIVIX-S 4386W (FXRD-4386WA) | |
| K252996 | 2026-06-12 | Konica Minolta Healthcare Americas, In… | Universal 1417PI | |
| K252911 | 2025-10-09 | Iray Imaging Technology (Haining) Limi… | Lux HD 2530 detector (Lux HD 2530) | |
| K250211 | 2025-07-22 | Innocare Optoelectronics Corp. | Yushan X-Ray Flat Panel Detector | |
| K250665 | 2025-06-17 | Konica Minolta, Inc. | SKR 3000 | |
| K243734 | 2025-04-18 | Allengers Medical Systems Limited | Wireless/ Wired X-Ray Flat Panel Detectors | |
| K242770 | 2025-03-20 | DRTECH Corporation | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | FDA |
| K243443 | 2025-03-19 | DRTECH Corporation | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; E… | |
| K243556 | 2025-03-18 | Iray Imaging Technology (Haining) Limi… | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (… | FDA |
| K244010 | 2025-02-24 | Jpi Healthcare Co, Ltd. | ExamVue Apex | |
| K243171 | 2024-12-19 | Innocare Optoelectronics Corp. | Yushan X-Ray Flat Panel Detector | |
| K241319 | 2024-11-21 | Konica Minolta, Inc. | SKR 3000 | |
| K241125 | 2024-11-15 | Vieworks Co., Ltd. | VIVIX-S 1751S | |
| K240771 | 2024-11-12 | Prognosys Medical Systems Private Limi… | PRORAD X-Ray Flat Panel Detector with DROC | |
| K241346 | 2024-11-07 | Aspen Imaging Healthcare, Inc. | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Pan… | |
| K242394 | 2024-09-09 | Rayence Co., Ltd. | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-… | |
| K240371 | 2024-03-07 | Rayence Co., Ltd. | 0909FCC, 0909FCC-HS | |
| K232082 | 2024-02-13 | DRTECH Corporation | EXPD 4343S | |
| K232753 | 2023-11-16 | DRTECH Corporation | EXPD 4343D; EXPD 3643D |
Official FDA classification page: MQB
Classification and pathway per current FDA publications. Data from openFDA (CC0).