LNHClass II
System, Nuclear Magnetic Resonance Imaging
21 CFR 892.1000 / Radiology
LNH is the FDA product code for System, Nuclear Magnetic Resonance Imaging, a class II device type, regulated under 21 CFR 892.1000. As of , FDA records hold 1,104 510(k) clearances under this code, the most recent dated , and 699 recalls.
Classification record
- Product code
- LNH
- Device name
- System, Nuclear Magnetic Resonance Imaging
- 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
- 1,107
- Ingested recalls
- 723
Clearances, product code LNH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1988 | 24 |
| 1989 | 40 |
| 1990 | 63 |
| 1991 | 58 |
| 1992 | 64 |
| 1993 | 59 |
| 1994 | 59 |
| 1995 | 45 |
| 1996 | 34 |
| 1997 | 25 |
| 1998 | 24 |
| 1999 | 26 |
| 2000 | 29 |
| 2001 | 27 |
| 2002 | 14 |
| 2003 | 25 |
| 2004 | 16 |
| 2005 | 23 |
| 2006 | 14 |
| 2007 | 12 |
| 2008 | 19 |
| 2009 | 17 |
| 2010 | 12 |
| 2011 | 16 |
| 2012 | 22 |
| 2013 | 19 |
| 2014 | 17 |
| 2015 | 19 |
| 2016 | 20 |
| 2017 | 18 |
| 2018 | 29 |
| 2019 | 26 |
| 2020 | 32 |
| 2021 | 27 |
| 2022 | 30 |
| 2023 | 30 |
| 2024 | 26 |
| 2025 | 26 |
| 2026 | 21 |
Applicants with the most clearances
Product code LNH| Applicant | Clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 136 |
| Philips North America LLC | 93 |
| GE Healthcare | 87 |
| Toshiba America Mri, Inc. | 62 |
| FUJIFILM Healthcare Americas Corporation | 60 |
| Medical Advances, Inc. | 38 |
| Canon Medical Systems Corporation | 31 |
| Philips Medical Systems Nederland B.V. | 30 |
| General Electric Co. | 29 |
| Esaote S.p.A. | 28 |
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.
