FDA product code MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)
MQB is the FDA product code for solid state x-ray imager (flat panel/digital imager). It is a Class II device, regulated under 21 CFR 892.1680 and reviewed by the Radiology panel. FDA has cleared 424 510(k) submissions under MQB, 60 in the last five years, from 131 different applicants. The average 510(k) review took 81 days (median 56); 156 days on average over the last three years. FDA has posted 195 recalls for MQB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class II |
| Regulation | 21 CFR 892.1680 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MQB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 31 | 64 |
| 2018 | 16 | 43 |
| 2019 | 22 | 36 |
| 2020 | 19 | 41 |
| 2021 | 21 | 64 |
| 2022 | 31 | 55 |
| 2023 | 10 | 51 |
| 2024 | 8 | 146 |
| 2025 | 8 | 118 |
| 2026 | 3 | 203 |
Compare with all 510(k) review times · Search every MQB clearance
Top MQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rayence Co., Ltd. | 29 | 2026-07-31 |
| Canon, Inc. | 27 | 2023-02-15 |
| Iray Technology Taicang , Ltd. | 17 | 2022-10-20 |
| Vieworks Co., Ltd. | 14 | 2026-06-18 |
| DRTECH Corporation | 14 | 2025-03-20 |
126 more applicants have MQB clearances. See the full list in Caduvo.
Most recent MQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253800 | Rayence Co., Ltd. | 0909FCE, 0909FCE-HS | 2026-07-31 | 245 |
| K260820 | Vieworks Co., Ltd. | VIVIX-S 4386W (FXRD-4386WA) | 2026-06-18 | 97 |
| K252996 | Konica Minolta Healthcare Americas, Inc. | Universal 1417PI | 2026-06-12 | 267 |
| K252911 | Iray Imaging Technology (Haining) Limited | Lux HD 2530 detector (Lux HD 2530) | 2025-10-09 | 27 |
| K250211 | Innocare Optoelectronics Corp. | Yushan X-Ray Flat Panel Detector | 2025-07-22 | 179 |
Recalls for MQB devices
195 product recalls in 113 recall events; 3 initiated in the last five years and 8 still open. Most recent: 2026-05-01.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 36 |
| 2019 | 1 |
| 2020 | 7 |
| 2021 | 3 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MQB?
MQB is the FDA product code for solid state x-ray imager (flat panel/digital imager). It is a Class II device, regulated under 21 CFR 892.1680 and reviewed by the Radiology panel.
What device class is MQB?
Class II, regulation 21 CFR 892.1680. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQB?
Across 424 cleared submissions the average was 81 days from receipt to decision (median 56).
Which companies have the most MQB clearances?
Rayence Co., Ltd. (29); Canon, Inc. (27); Iray Technology Taicang , Ltd. (17); Vieworks Co., Ltd. (14); DRTECH Corporation (14).
Have MQB devices been recalled?
Yes: 195 product recalls across 113 recall events; the most recent began 2026-05-01.
Next steps
- Run an FDA pathway report with predicate devices for product code MQB
- Run a recall and safety report across every MQB manufacturer
- Watch product code MQB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times