FDA product code · Radiology · Class 2
LNH: System, Nuclear Magnetic Resonance Imaging
LNH is FDA's product code for "System, Nuclear Magnetic Resonance Imaging": a Class 2 device classified under 21 CFR 892.1000, reviewed by the Radiology panel.
510(k) review time for LNH
Across 247 510(k) clearances under LNH decided from 2018-01-01 to 2026-10-06, the median was 101 days from FDA receipt to decision. Half took between 57 and 153 days, and 80% were decided within 170 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 57 |
| Median | 101 |
| 75th percentile | 153 |
| 80th percentile | 170 |
| 90th percentile | 217 |
| Slowest | 613 |
| Year | Median days | n |
|---|---|---|
| 2018 | 128 | 29 |
| 2019 | 62 | 26 |
| 2020 | 121 | 32 |
| 2021 | 87 | 27 |
| 2022 | 74 | 30 |
| 2023 | 124 | 30 |
| 2024 | 104 | 26 |
| 2025 | 122 | 26 |
| 2026 (to 10-06, partial) | 124 | 21 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
LNH in the public FDA record
| 510(k) clearances, all years | 1,105 |
|---|---|
| Device recalls | 699 |
| Establishment listings | 1,064 |
| GUDID device identifiers | 1,517 |
Counts of records, not of devices or events. Adverse event reports for LNH are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite LNH
15 FDA recognized consensus standards cite LNH, among them NEMA MS 3-2008 (R2020); NEMA MS-1-2008 (R2020); NEMA MS 6-2008 (R2014 R2020). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-187 NEMA MS 3-2008 (R2020) — Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- 12-188 NEMA MS-1-2008 (R2020) — Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
- 12-195 NEMA MS 6-2008 (R2014 R2020) — Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- 12-196 NEMA MS 2-2008 (R2020) — Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- 12-264 NEMA MS 11-2010 — Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
- 12-288 NEMA MS 9-2008 (R2020) — Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- 12-292 IEEE Std 3333.2.1-2015 — IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
- 12-298 NEMA MS 10-2010 — Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
- 12-306 NEMA MS 12-2016 — Quantification and Mapping of Geometric Distortion for Special Applications
- 12-315 NEMA MS 8-2016 (R2003) — Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
- 12-322 NEMA MS 5-2018 — Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- 12-331 NEMA Standards Publication MS 14-2019 — Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
- 12-332 IEC 62464-1 Edition 2.0 2018-12 — Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
- 12-347 IEC 60601-2-33 Edition 4.0 2022-08 — Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- 12-354 NEMA MS 4-2023 — Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.