MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) Class II
FDA Device Classification
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 |
|---|
| 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 |
| K232058 | careray digital medical technology co | YosemiteView 4343W/YosemiteView 3643W | August 3, 2023 |
| K231959 | drtech corporation | EXPD 4357; EXPD 4357P | August 1, 2023 |