FDA product code LNI: System, Nuclear Magnetic Resonance Spectroscopic
LNI is the FDA product code for system, nuclear magnetic resonance spectroscopic. It is a Class II device, regulated under 21 CFR 892.1000 and reviewed by the Radiology panel. FDA has cleared 10 510(k) submissions under LNI, from 7 different applicants. The average 510(k) review took 173 days (median 82). FDA has posted 17 recalls for LNI devices, 16 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Nuclear Magnetic Resonance Spectroscopic |
| 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 |
Top LNI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GE Medical Systems | 3 | 2001-01-17 |
| Hitachi Medical Systems America, Inc. | 2 | 2010-03-16 |
| Ge Medical Systems, Inc. | 1 | 2001-08-22 |
| Toshiba America Medical Systems, In.C | 1 | 2001-04-05 |
| Philips Medical Systems (Cleveland), Inc. | 1 | 1999-07-19 |
2 more applicants have LNI clearances. See the full list in Caduvo.
Most recent LNI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093044 | Hitachi Medical Systems America, Inc. | OASIS MRI SYSTEM | 2010-03-16 | 167 |
| K071506 | Hitachi Medical Systems America, Inc. | ECHELON SPECTROSCOPY PACKAGE | 2007-06-28 | 27 |
| K011604 | Ge Medical Systems, Inc. | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI | 2001-08-22 | 90 |
| K010129 | Toshiba America Medical Systems, In.C | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | 2001-04-05 | 79 |
| K003575 | GE Medical Systems | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | 2001-01-17 | 58 |
Recalls for LNI devices
17 product recalls in 3 recall events; 16 initiated in the last five years and 17 still open. Most recent: 2024-01-03.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 4 |
| 2024 | 12 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C8919 — Magnetic resonance angiography without contrast, pelvis
- C8918 — Magnetic resonance angiography with contrast, pelvis
- C8900 — Magnetic resonance angiography with contrast, abdomen
- C8901 — Magnetic resonance angiography without contrast, abdomen
- C8912 — Magnetic resonance angiography with contrast, lower extremity
Frequently asked questions
What is FDA product code LNI?
LNI is the FDA product code for system, nuclear magnetic resonance spectroscopic. It is a Class II device, regulated under 21 CFR 892.1000 and reviewed by the Radiology panel.
What device class is LNI?
Class II, regulation 21 CFR 892.1000. Typical premarket route: 510(k).
How long does a 510(k) take for product code LNI?
Across 10 cleared submissions the average was 173 days from receipt to decision (median 82).
Which companies have the most LNI clearances?
GE Medical Systems (3); Hitachi Medical Systems America, Inc. (2); Ge Medical Systems, Inc. (1); Toshiba America Medical Systems, In.C (1); Philips Medical Systems (Cleveland), Inc. (1).
Have LNI devices been recalled?
Yes: 17 product recalls across 3 recall events; the most recent began 2024-01-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LNI
- Run a recall and safety report across every LNI manufacturer
- Watch product code LNI 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.