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-staging.innolitics.com/productcode/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 424)

Showing 20 most recent of 424 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253800](/device/K253800.md) | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | Jul 31, 2026 | SESE |
| [K260820](/device/K260820.md) | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | Jun 18, 2026 | SESE |
| [K252996](/device/K252996.md) | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | Jun 12, 2026 | SESE |
| [K252911](/device/K252911.md) | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | Oct 9, 2025 | SESE |
| [K250211](/device/K250211.md) | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Jul 22, 2025 | SESE |
| [K250665](/device/K250665.md) | SKR 3000 | Konica Minolta, Inc. | Jun 17, 2025 | SESE |
| [K243734](/device/K243734.md) | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | Apr 18, 2025 | SESE |
| [K242770](/device/K242770.md) | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | Mar 20, 2025 | SESE |
| [K243443](/device/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](/device/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](/device/K244010.md) | ExamVue Apex | Jpi Healthcare Co, Ltd. | Feb 24, 2025 | SESE |
| [K243171](/device/K243171.md) | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Dec 19, 2024 | SESE |
| [K241319](/device/K241319.md) | SKR 3000 | Konica Minolta, Inc. | Nov 21, 2024 | SESE |
| [K241125](/device/K241125.md) | VIVIX-S 1751S | Vieworks Co., Ltd. | Nov 15, 2024 | SESE |
| [K240771](/device/K240771.md) | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | Nov 12, 2024 | SESE |
| [K241346](/device/K241346.md) | IODR1717 / IODR1417 / IODR1417-GF  (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | Nov 7, 2024 | SESE |
| [K242394](/device/K242394.md) | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | Sep 9, 2024 | SESE |
| [K240371](/device/K240371.md) | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | Mar 7, 2024 | SESE |
| [K232082](/device/K232082.md) | EXPD 4343S | DRTECH Corporation | Feb 13, 2024 | SESE |
| [K232753](/device/K232753.md) | EXPD 4343D; EXPD 3643D | DRTECH Corporation | Nov 16, 2023 | SESE |

## Top Applicants

- Rayence Co., Ltd. — 29 clearances
- Canon, Inc. — 27 clearances
- Iray Technology Taicang , Ltd. — 17 clearances
- DRTECH Corporation — 14 clearances
- Vieworks Co., Ltd. — 14 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/MQB](https://fda-staging.innolitics.com/productcode/MQB)

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