FDA product code · Radiology
LNHSystem, Nuclear Magnetic Resonance Imaging
Product code LNH covers System, Nuclear Magnetic Resonance Imaging, a Class II device regulated under 21 CFR 892.1000. FDA has cleared 1,099 devices in this code, 22 of them in the last 12 months. Median review time across the 1,099 most recent decisions is 86 days. openFDA lists 699 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1000
- Review panel
- Radiology
- Clearances
- 1,099
What is happening in LNH right now?
LNH (System, Nuclear Magnetic Resonance Imaging) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1951-2026, Z-1952-2026, Z-1953-2026, Z-1954-2026, Z-1955-2026). 3 first-time filers in the last 12 months, including Eyas Medical Imaging, Inc. and Fujifilm Corporation (K253499, K251386, K251029). Clearances are running 22% slower — a median 105 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (LNH:review_time:12m). The code is crowded, scoring 94 of 100 — 197 companies hold a clearance here and 22 arrived in the last 12 months (LNH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1951-2026, Z-1952-2026, Z-1953-2026, Z-1954-2026, Z-1955-2026 |
| New entrant | Worth knowing | K253499, K251386, K251029 |
| Review time | Context | LNH:review_time:12m |
| Crowding | Context | LNH:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LNH?
FDA has cleared 1,099 devices under product code LNH since the 510(k) programme began in 1976, 22 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. |
How long does FDA review take for LNH?
The median FDA review time for LNH is 86 days, measured across the 1,099 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 LNH?
openFDA lists 699 recall records against product code LNH. A recall record covers one firm's corrective action and may span many device lots.
Z-1951-2026Open, ClassifiedPhilips North America LLC
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1952-2026Open, ClassifiedPhilips North America LLC
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1953-2026Open, ClassifiedPhilips North America LLC
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1954-2026Open, ClassifiedPhilips North America LLC
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Z-1955-2026Open, ClassifiedPhilips North America LLC
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Showing the 5 most recently initiated of 699. 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 LNH?
MAUDE holds 1,657 adverse-event reports naming product code LNH, 356 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 LNH unusual?
One month sits above LNH's own expected range: 1 January 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 63 | Insufficient history | No expected range — too little history | |
| 54 | Insufficient history | No expected range — too little history | |
| 286 | 3–72 | Above expected (3–72) | |
| 187 | 0–233 | Within expected (0–233) | |
| 146 | 0–316 | Within expected (0–316) | |
| 105 | 0–332 | Within expected (0–332) | |
| 59 | 0–297 | Within expected (0–297) | |
| 48 | 0–283 | Within expected (0–283) | |
| 58 | 0–409 | Within expected (0–409) | |
| 55 | 0–285 | Within expected (0–285) | |
| 48 | 0–284 | Within expected (0–284) | |
| 61 | 0–271 | Within expected (0–271) | |
| 38 | 0–239 | Within expected (0–239) | |
| 61 | 0–260 | Within expected (0–260) | |
| 36 | 0–304 | Within expected (0–304) | |
| 40 | 0–187 | Within expected (0–187) | |
| 33 | 0–144 | Within expected (0–144) |
21 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. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in LNH.
Who has entered LNH in the last year?
3 companies filed in LNH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Eyas Medical Imaging, Inc. | K253499 | |
| Fujifilm Corporation | K251386 | |
| Vista AI, Inc. | K251029 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in LNH?
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 LNH?
Across the 1,099 most recent decisions, these applicants filed most often in LNH.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 135 |
| Toshiba America Mri, Inc. | 62 |
| Philips Medical Systems (Cleveland), Inc. | 57 |
| Hitachi Medical Systems America, Inc. | 54 |
| GE Medical Systems | 39 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in LNH files 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 |
|---|---|---|
| GE Medical Systems, LLC | 81 | 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 LNH
Get an email the morning anything changes in LNH — 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.