FDA product code MOS: Coil, Magnetic Resonance, Specialty
MOS is the FDA product code for coil, magnetic resonance, specialty. It is a Class II device, regulated under 21 CFR 892.1000 and reviewed by the Radiology panel. FDA has cleared 490 510(k) submissions under MOS, 43 in the last five years, from 97 different applicants. The average 510(k) review took 63 days (median 51); 86 days on average over the last three years. FDA has posted 38 recalls for MOS devices, 16 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Coil, Magnetic Resonance, Specialty |
| Device class | Class II |
| Regulation | 21 CFR 892.1000 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 68 |
| 2018 | 10 | 82 |
| 2019 | 3 | 152 |
| 2020 | 5 | 96 |
| 2021 | 4 | 47 |
| 2022 | 11 | 153 |
| 2023 | 10 | 119 |
| 2024 | 10 | 53 |
| 2025 | 3 | 112 |
| 2026 | 9 | 93 |
Compare with all 510(k) review times · Search every MOS clearance
Top MOS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Usa Instruments, Inc. | 63 | 2005-11-09 |
| Mri Devices Corp. | 60 | 2004-07-19 |
| Quality Electrodynamics, LLC | 20 | 2023-01-13 |
| Medical Advances, Inc. | 19 | 2002-12-16 |
| Hitachi Medical Systems America, Inc. | 18 | 2016-09-16 |
92 more applicants have MOS clearances. See the full list in Caduvo.
Most recent MOS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262330 | Philips Medical Systems Nederland B.V. | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | 2026-07-30 | 21 |
| K262294 | Philips Medical Systems Nederland B.V. | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | 2026-07-24 | 17 |
| K260947 | Neocoil, LLC | 0.55T 12Ch Breast Coil | 2026-04-23 | 31 |
| K252587 | Shenzhen RF Tech Co., Ltd. | HD 8Ch Wrist Array | 2026-04-14 | 242 |
| K252876 | Shenzhen RF Tech Co., Ltd. | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | 2026-04-01 | 203 |
Recalls for MOS devices
38 product recalls in 17 recall events; 16 initiated in the last five years and 16 still open. Most recent: 2024-11-04.
| Year | Recalls |
|---|---|
| 2019 | 8 |
| 2020 | 1 |
| 2024 | 16 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C8901 — Magnetic resonance angiography without contrast, abdomen
- C8918 — Magnetic resonance angiography with contrast, pelvis
- C8900 — Magnetic resonance angiography with contrast, abdomen
- C8919 — Magnetic resonance angiography without contrast, pelvis
- C8912 — Magnetic resonance angiography with contrast, lower extremity
Frequently asked questions
What is FDA product code MOS?
MOS is the FDA product code for coil, magnetic resonance, specialty. It is a Class II device, regulated under 21 CFR 892.1000 and reviewed by the Radiology panel.
What device class is MOS?
Class II, regulation 21 CFR 892.1000. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOS?
Across 490 cleared submissions the average was 63 days from receipt to decision (median 51).
Which companies have the most MOS clearances?
Usa Instruments, Inc. (63); Mri Devices Corp. (60); Quality Electrodynamics, LLC (20); Medical Advances, Inc. (19); Hitachi Medical Systems America, Inc. (18).
Have MOS devices been recalled?
Yes: 38 product recalls across 17 recall events; the most recent began 2024-11-04.
Next steps
- Run an FDA pathway report with predicate devices for product code MOS
- Run a recall and safety report across every MOS manufacturer
- Watch product code MOS 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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