FDA product code · Radiology · Class 2
MUH: System, X-Ray, Extraoral Source, Digital
MUH is FDA's product code for "System, X-Ray, Extraoral Source, Digital": a Class 2 device classified under 21 CFR 872.1800, reviewed by the Radiology panel.
510(k) review time for MUH
Across 49 510(k) clearances under MUH decided from 2018-01-01 to 2026-10-06, the median was 61 days from FDA receipt to decision. Half took between 29 and 154 days, and 80% were decided within 178 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 29 |
| Median | 61 |
| 75th percentile | 154 |
| 80th percentile | 178 |
| 90th percentile | 233 |
| Slowest | 392 |
| Year | Median days | n |
|---|---|---|
| 2019 | 64 | 5 |
| 2020 | 36 | 5 |
| 2021 | 80 | 10 |
| 2022 | 57 | 7 |
| 2023 | 57 | 11 |
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.
MUH in the public FDA record
| 510(k) clearances, all years | 206 |
|---|---|
| Device recalls | 9 |
| Establishment listings | 183 |
| GUDID device identifiers | 1,038 |
Counts of records, not of devices or events. Adverse event reports for MUH 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 MUH
3 FDA recognized consensus standards cite MUH, among them IEC 61223-3-4 First edition 2000-03; IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION; IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-221 IEC 61223-3-4 First edition 2000-03 — Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
- 12-339 IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
- 12-340 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.