MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) Class II
FDA product code MQB covers "Solid State X-Ray Imager (Flat Panel/Digital Imager)", a Class II medical device regulated under 21 CFR 892.1680. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQB
- Device Class
- Class II
- Regulation Number
- 892.1680
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253800 | Rayence Co | 0909FCE, 0909FCE-HS | Jul 31, 2026 |
| K260820 | Vieworks Co | VIVIX-S 4386W (FXRD-4386WA) | Jun 18, 2026 |
| K252996 | Konica Minolta Healthcare Americas | Universal 1417PI | Jun 12, 2026 |
| K252911 | Iray Imaging Technology (Haining) Limited | Lux HD 2530 detector (Lux HD 2530) | Oct 9, 2025 |
| K250211 | Innocare Optoelectronics | Yushan X-Ray Flat Panel Detector | Jul 22, 2025 |
| K250665 | Konica Minolta | SKR 3000 | Jun 17, 2025 |
| K243734 | Allengers Medical Systems Limited | Wireless/ Wired X-Ray Flat Panel Detectors | Apr 18, 2025 |
| K242770 | Drtech Corporation | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | Mar 20, 2025 |
| K243443 | Drtech Corporation | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP | Mar 19, 2025 |
| K243556 | Iray Imaging Technology (Haining) Limited | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Mar 18, 2025 |
| K244010 | Jpi Healthcare Co | ExamVue Apex | Feb 24, 2025 |
| K243171 | Innocare Optoelectronics | Yushan X-Ray Flat Panel Detector | Dec 19, 2024 |
| K241319 | Konica Minolta | SKR 3000 | Nov 21, 2024 |
| K241125 | Vieworks Co | VIVIX-S 1751S | Nov 15, 2024 |
| K240771 | Prognosys Medical Systems Private Limited | PRORAD X-Ray Flat Panel Detector with DROC | Nov 12, 2024 |
| K241346 | Aspen Imaging Healthcare | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Nov 7, 2024 |
| K242394 | Rayence Co | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Sep 9, 2024 |
| K240371 | Rayence Co | 0909FCC, 0909FCC-HS | Mar 7, 2024 |
| K232082 | Drtech Corporation | EXPD 4343S | Feb 13, 2024 |
| K232753 | Drtech Corporation | EXPD 4343D; EXPD 3643D | Nov 16, 2023 |