FDA product code · Radiology
MOSCoil, Magnetic Resonance, Specialty
Product code MOS covers Coil, Magnetic Resonance, Specialty, a Class II device regulated under 21 CFR 892.1000. FDA has cleared 489 devices in this code, 9 of them in the last 12 months. Median review time across the 489 most recent decisions is 51 days. openFDA lists 38 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1000
- Review panel
- Radiology
- Clearances
- 489
What is happening in MOS right now?
MOS (Coil, Magnetic Resonance, Specialty): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in MOS?
FDA has cleared 489 devices under product code MOS since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262294 | 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 | Philips Medical Systems Nederland B.V. | |
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | |
| K252876 | 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 | Shenzhen RF Tech Co., Ltd. | |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. | |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. | |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. |
How long does FDA review take for MOS?
The median FDA review time for MOS is 51 days, measured across the 489 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MOS?
openFDA lists 38 recall records against product code MOS. A recall record covers one firm's corrective action and may span many device lots.
Z-0536-2025Open, ClassifiedPhilips North America LLC
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0537-2025Open, ClassifiedPhilips North America LLC
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0538-2025Open, ClassifiedPhilips North America LLC
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0539-2025Open, ClassifiedPhilips North America LLC
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Z-0540-2025Open, ClassifiedPhilips North America LLC
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Showing the 5 most recently initiated of 38. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MOS?
MAUDE holds 15 adverse-event reports naming product code MOS, 1 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MOS unusual?
MOS does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
10 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in MOS?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MOS?
Across the 489 most recent decisions, these applicants filed most often in MOS.
| Applicant | Recent clearances |
|---|---|
| Usa Instruments, Inc. | 63 |
| Mri Devices Corp. | 60 |
| Quality Electrodynamics, LLC | 20 |
| Medical Advances, Inc. | 19 |
| Hitachi Medical Systems America, Inc. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in MOS file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Mri Devices Corporation | 65 | 2 |
| Quality Electrodynamics LLC | 33 | 2 |
| Invivo Corporation | 21 | 3 |
| GE Medical Systems, LLC | 19 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MOS
Get an email the morning anything changes in MOS — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.