MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager)
Radiology · 21 CFR 892.1680 · Class 2
Overview
| Product Code | MQB |
|---|---|
| Device Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 421)
Showing 20 most recent of 421 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | Oct 9, 2025 | SESE |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Jul 22, 2025 | SESE |
| K250665 | SKR 3000 | Konica Minolta, Inc. | Jun 17, 2025 | SESE |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | Apr 18, 2025 | SESE |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | Mar 20, 2025 | SESE |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | Mar 19, 2025 | SESE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | Mar 18, 2025 | SESE |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | Feb 24, 2025 | SESE |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Dec 19, 2024 | SESE |
| K241319 | SKR 3000 | Konica Minolta, Inc. | Nov 21, 2024 | SESE |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | Nov 15, 2024 | SESE |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | Nov 12, 2024 | SESE |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | Nov 7, 2024 | SESE |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | Sep 9, 2024 | SESE |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | Mar 7, 2024 | SESE |
| K232082 | EXPD 4343S | DRTECH Corporation | Feb 13, 2024 | SESE |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | Nov 16, 2023 | SESE |
| K230918 | MasterX 800 Series | Medicatech USA | Sep 1, 2023 | SESE |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | Aug 3, 2023 | SESE |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | Aug 1, 2023 | SESE |
Top Applicants
- Rayence Co., Ltd. — 28 clearances
- Canon, Inc. — 27 clearances
- Iray Technology Taicang , Ltd. — 17 clearances
- DRTECH Corporation — 14 clearances
- Agfa Healthcare N.V. — 13 clearances
