FDA product code · Radiology · Class 2
MUE: Full Field Digital, System, X-Ray, Mammographic
MUE is FDA's product code for "Full Field Digital, System, X-Ray, Mammographic": a Class 2 device classified under 21 CFR 892.1715, reviewed by the Radiology panel.
510(k) review time for MUE
Across 24 510(k) clearances under MUE decided from 2018-01-01 to 2026-10-06, the median was 192 days from FDA receipt to decision. Half took between 121 and 266 days, and 80% were decided within 314 days. These are past clearances, not a forecast for a new submission.
| Fastest | 60 |
|---|---|
| 25th percentile | 121 |
| Median | 192 |
| 75th percentile | 266 |
| 80th percentile | 314 |
| 90th percentile | 408 |
| Slowest | 447 |
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.
MUE in the public FDA record
| 510(k) clearances, all years | 56 |
|---|---|
| Device recalls | 41 |
| Establishment listings | 121 |
Counts of records, not of devices or events. Adverse event reports for MUE 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 MUE
6 FDA recognized consensus standards cite MUE, among them NEMA XR 22-2006 (R2020); NEMA XR 23-2006 (R2020); IEC 61223-3-2 Second eidtion 2007-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-165 NEMA XR 22-2006 (R2020) — Quality Control Manual Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
- 12-166 NEMA XR 23-2006 (R2020) — Quality Control Manual Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
- 12-176 IEC 61223-3-2 Second eidtion 2007-07 — Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
- 12-213 IEC 62220-1-2 Edition 1.0 2007-06 — Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
- 12-365 IEC 60627 Edition 3.0 2013-07 — Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
- 12-366 IEC 61223-3-6 Edition 1.0 2020-02 — Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.