Product code LNH: 510(k) clearances and predicates
Product code LNH covers Embrace Vision Neonatal MRI System. FDA lists 1107 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
1107 clearances on file under product code LNH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 30 |
| 2023 | 30 |
| 2024 | 26 |
| 2025 | 26 |
| 2026 so far | 21 |
Recent clearances
Newest LNH clearances in the FDA index, with applicant and decision date:
- K261758, Embrace Vision Neonatal MRI System, applicant Aspect Imaging, Ltd., decided 2026-09-16. FDA record
- K261283, APERTO Lucent MRI System, applicant Fujifilm Corporation, decided 2026-09-16. FDA record
- K260758, MAGNETOM Free.Max; MAGNETOM Free.Star, applicant Siemens Shenzhen Magnetic Resonance , Ltd., decided 2026-09-01. FDA record
- K262622, Swoop® Portable MR Imaging® System, applicant Hyperfine, Inc., decided 2026-08-19. FDA record
- K254250, MagicScan-1.5, GreenMR Serenity 1.5T, applicant Xingaoyi Medical Equipment Co.,Ltd, decided 2026-08-17. FDA record
- K253808, AIR Recon DL, applicant GE Medical Systems, decided 2026-08-13. FDA record
- K261331, I-Genius (100019400), applicant Esaote, S.p.A., decided 2026-07-31. FDA record
- K260852, MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure, applicant Siemens Healthineers AG, decided 2026-07-31. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include APERTO Lucent MRI System, MAGNETOM Free.Max; MAGNETOM Free.Star. Watch new LNH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LNH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LNH clearances include Embrace Vision Neonatal MRI System.
How many 510(k) clearances use product code LNH?
1107 at the time this page was generated, from openFDA records.
How do I find a predicate device under LNH?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LNH clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.