FDA product code · Radiology · Class 2
MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)
MQB is FDA's product code for "Solid State X-Ray Imager (Flat Panel/Digital Imager)": a Class 2 device classified under 21 CFR 892.1680, reviewed by the Radiology panel.
510(k) review time for MQB
Across 138 510(k) clearances under MQB decided from 2018-01-01 to 2026-10-06, the median was 36 days from FDA receipt to decision. Half took between 26 and 68 days, and 80% were decided within 84 days. These are past clearances, not a forecast for a new submission.
| Fastest | 11 |
|---|---|
| 25th percentile | 26 |
| Median | 36 |
| 75th percentile | 68 |
| 80th percentile | 84 |
| 90th percentile | 145 |
| Slowest | 267 |
| Year | Median days | n |
|---|---|---|
| 2018 | 30 | 16 |
| 2019 | 30 | 22 |
| 2020 | 28 | 19 |
| 2021 | 48 | 21 |
| 2022 | 48 | 31 |
| 2023 | 30 | 10 |
| 2024 | 187 | 8 |
| 2025 | 127 | 8 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MQB in the public FDA record
| 510(k) clearances, all years | 424 |
|---|---|
| Device recalls | 195 |
| Establishment listings | 691 |
| GUDID device identifiers | 1,716 |
Counts of records, not of devices or events. Adverse event reports for MQB are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MQB
10 FDA recognized consensus standards cite MQB, 1 of them recognized only in part, among them IEC 62220-1-3 Edition 1.0 2008-06; IEC 62494-1 Edition 1.0 (2008-08); NEMA XR 24-2008 (R2014). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-214 IEC 62220-1-3 Edition 1.0 2008-06 — Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
- 12-215 IEC 62494-1 Edition 1.0 (2008-08) — Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
- 12-230 NEMA XR 24-2008 (R2014) — Primary user controls for interventional angiography x-ray equipment
- 12-289 IEC 62220-1-1 Edition 1.0 2015-03 — Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
- 12-290 IEC 61910-1 Edition 1.0 2014-09 — Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
- 12-348 IEC 60601-2-54 Edition 2.0 2022-09 (partial recognition) — Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- 12-351 IEC 60601-2-43 Edition 3.0 2022-12 — Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
- 12-363 NEMA PS 3.1 - 3.20 2024e — Digital Imaging and Communications in Medicine (DICOM) Set
- 12-364 IEC 61223-3-8 Edition 1.0 2024-03 — Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
- 12-385 NEMA PS 3.1 - 3.20 2025d — Digital Imaging and Communications in Medicine (DICOM) Set
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.