Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) → MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) # MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager) _Radiology · 21 CFR 892.1680 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB ## Overview - **Product Code:** MQB - **Device Name:** Solid State X-Ray Imager (Flat Panel/Digital Imager) - **Regulation:** [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K252911.md) | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | Oct 9, 2025 | SESE | | [K250211](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K250211.md) | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Jul 22, 2025 | SESE | | [K250665](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K250665.md) | SKR 3000 | Konica Minolta, Inc. | Jun 17, 2025 | SESE | | [K243734](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K243734.md) | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | Apr 18, 2025 | SESE | | [K242770](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K242770.md) | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | Mar 20, 2025 | SESE | | [K243443](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K243443.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K243556.md) | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | Mar 18, 2025 | SESE | | [K244010](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K244010.md) | ExamVue Apex | Jpi Healthcare Co, Ltd. | Feb 24, 2025 | SESE | | [K243171](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K243171.md) | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Dec 19, 2024 | SESE | | [K241319](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K241319.md) | SKR 3000 | Konica Minolta, Inc. | Nov 21, 2024 | SESE | | [K241125](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K241125.md) | VIVIX-S 1751S | Vieworks Co., Ltd. | Nov 15, 2024 | SESE | | [K240771](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K240771.md) | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | Nov 12, 2024 | SESE | | [K241346](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K241346.md) | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | Nov 7, 2024 | SESE | | [K242394](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K242394.md) | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | Sep 9, 2024 | SESE | | [K240371](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K240371.md) | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | Mar 7, 2024 | SESE | | [K232082](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K232082.md) | EXPD 4343S | DRTECH Corporation | Feb 13, 2024 | SESE | | [K232753](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K232753.md) | EXPD 4343D; EXPD 3643D | DRTECH Corporation | Nov 16, 2023 | SESE | | [K230918](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K230918.md) | MasterX 800 Series | Medicatech USA | Sep 1, 2023 | SESE | | [K232058](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K232058.md) | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | Aug 3, 2023 | SESE | | [K231959](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K231959.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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