MOSClass II
Coil, Magnetic Resonance, Specialty
21 CFR 892.1000 / Radiology
MOS is the FDA product code for Coil, Magnetic Resonance, Specialty, a class II device type, regulated under 21 CFR 892.1000. As of , FDA records hold 490 510(k) clearances under this code, the most recent dated , and 38 recalls.
Classification record
- Product code
- MOS
- Device name
- Coil, Magnetic Resonance, Specialty
- Regulation
- 21 CFR 892.1000
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 490
- Ingested recalls
- 38
Clearances, product code MOS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 17 |
| 1998 | 20 |
| 1999 | 22 |
| 2000 | 41 |
| 2001 | 26 |
| 2002 | 41 |
| 2003 | 43 |
| 2004 | 21 |
| 2005 | 23 |
| 2006 | 15 |
| 2007 | 16 |
| 2008 | 19 |
| 2009 | 10 |
| 2010 | 16 |
| 2011 | 25 |
| 2012 | 15 |
| 2013 | 7 |
| 2014 | 12 |
| 2015 | 6 |
| 2016 | 11 |
| 2017 | 9 |
| 2018 | 10 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 4 |
| 2022 | 11 |
| 2023 | 10 |
| 2024 | 10 |
| 2025 | 3 |
| 2026 | 9 |
Applicants with the most clearances
Product code MOS| Applicant | Clearances |
|---|---|
| Mri Devices Corp. | 65 |
| GE Healthcare Coils | 63 |
| Quality Electrodynamics | 33 |
| GE Healthcare | 21 |
| Invivo Corporation | 21 |
| Medical Advances, Inc. | 19 |
| FUJIFILM Healthcare Americas Corporation | 18 |
| Medrad, Inc. | 18 |
| NeoCoil, LLC | 18 |
| GE Healthcare Coils (USA Instruments, Inc.) | 11 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
