FDA product code MUH: System, X-Ray, Extraoral Source, Digital
MUH is the FDA product code for system, x-ray, extraoral source, digital. It is a Class II device, regulated under 21 CFR 872.1800 and reviewed by the Radiology panel. FDA has cleared 206 510(k) submissions under MUH, 26 in the last five years, from 118 different applicants. The average 510(k) review took 101 days (median 72); 192 days on average over the last three years. FDA has posted 9 recalls for MUH devices.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Extraoral Source, Digital |
| Device class | Class II |
| Regulation | 21 CFR 872.1800 |
| Review panel | RA — Radiology |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MUH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 98 |
| 2018 | 3 | 82 |
| 2019 | 5 | 74 |
| 2020 | 5 | 75 |
| 2021 | 10 | 109 |
| 2022 | 7 | 54 |
| 2023 | 11 | 86 |
| 2024 | 4 | 152 |
| 2025 | 3 | 160 |
| 2026 | 1 | 265 |
Compare with all 510(k) review times · Search every MUH clearance
Top MUH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| VATECH Co., Ltd. | 8 | 2024-10-25 |
| Genoray Co., Ltd. | 7 | 2023-09-13 |
| Sirona Dental Systems GmbH | 7 | 2008-08-26 |
| Trophy | 6 | 2015-08-21 |
| Ray Co., Ltd. | 5 | 2024-04-18 |
113 more applicants have MUH clearances. See the full list in Caduvo.
Most recent MUH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251793 | Sota Cloud Corp. | SOTA Cloud Smart Sensor (1.5) | 2026-03-03 | 265 |
| K252570 | Qpix Solutions, Inc. | EzSensor HD, EzSensor UHD | 2025-11-10 | 88 |
| K250687 | Dexcowin Global, Inc. | Cocoon Solo (DX-7020s) | 2025-10-24 | 232 |
| K251206 | Dentimax, Inc. | Digital X-Ray DentiMax Pro Imaging System | 2025-09-24 | 159 |
| K240040 | VATECH Co., Ltd. | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | 2024-10-25 | 294 |
Recalls for MUH devices
9 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-29.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code MUH?
MUH is the FDA product code for system, x-ray, extraoral source, digital. It is a Class II device, regulated under 21 CFR 872.1800 and reviewed by the Radiology panel.
What device class is MUH?
Class II, regulation 21 CFR 872.1800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUH?
Across 206 cleared submissions the average was 101 days from receipt to decision (median 72).
Which companies have the most MUH clearances?
VATECH Co., Ltd. (8); Genoray Co., Ltd. (7); Sirona Dental Systems GmbH (7); Trophy (6); Ray Co., Ltd. (5).
Have MUH devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2019-04-29.
Next steps
- Run an FDA pathway report with predicate devices for product code MUH
- Run a recall and safety report across every MUH manufacturer
- Watch product code MUH 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.
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