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 |
|---|---|---|---|
| K260820 | vieworks co | VIVIX-S 4386W (FXRD-4386WA) | June 18, 2026 |
| K252996 | konica minolta healthcare americas | Universal 1417PI | June 12, 2026 |
| K252911 | iray imaging technology (haining) limited | Lux HD 2530 detector (Lux HD 2530) | October 9, 2025 |
| K250211 | innocare optoelectronics | Yushan X-Ray Flat Panel Detector | July 22, 2025 |
| K250665 | konica minolta | SKR 3000 | June 17, 2025 |
| K243734 | allengers medical systems limited | Wireless/ Wired X-Ray Flat Panel Detectors | April 18, 2025 |
| K242770 | drtech corporation | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | March 20, 2025 |
| K243443 | drtech corporation | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP | March 19, 2025 |
| K243556 | iray imaging technology (haining) limited | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | March 18, 2025 |
| K244010 | jpi healthcare co | ExamVue Apex | February 24, 2025 |
| K243171 | innocare optoelectronics | Yushan X-Ray Flat Panel Detector | December 19, 2024 |
| K241319 | konica minolta | SKR 3000 | November 21, 2024 |
| K241125 | vieworks co | VIVIX-S 1751S | November 15, 2024 |
| K240771 | prognosys medical systems private limited | PRORAD X-Ray Flat Panel Detector with DROC | November 12, 2024 |
| K241346 | aspen imaging healthcare | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | November 7, 2024 |
| K242394 | rayence co | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | September 9, 2024 |
| K240371 | rayence co | 0909FCC, 0909FCC-HS | March 7, 2024 |
| K232082 | drtech corporation | EXPD 4343S | February 13, 2024 |
| K232753 | drtech corporation | EXPD 4343D; EXPD 3643D | November 16, 2023 |
| K230918 | medicatech usa | MasterX 800 Series | September 1, 2023 |