FDA product code LNH: System, Nuclear Magnetic Resonance Imaging

LNH is the FDA product code for system, nuclear magnetic resonance imaging. It is a Class II device, regulated under 21 CFR 892.1000 and reviewed by the Radiology panel. FDA has cleared 1,107 510(k) submissions under LNH, 133 in the last five years, from 211 different applicants. The average 510(k) review took 110 days (median 86); 123 days on average over the last three years. 11 PMA applications cite this product code. FDA has posted 723 recalls for LNH devices, 354 initiated in the last five years.

Classification

Field	Value
Device name	System, Nuclear Magnetic Resonance Imaging
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

510(k) clearances per year for LNH

Year	Clearances	Avg. review days
2017	18	116
2018	29	122
2019	26	84
2020	32	115
2021	27	114
2022	30	115
2023	30	128
2024	26	119
2025	26	122
2026	21	129

Compare with all 510(k) review times · Search every LNH clearance

Top LNH applicants

Applicant	Clearances	Latest
Siemens Medical Solutions USA, Inc.	135	2024-03-29
Toshiba America Mri, Inc.	62	2000-10-26
Philips Medical Systems (Cleveland), Inc.	57	2003-02-04
Hitachi Medical Systems America, Inc.	54	2016-05-20
GE Medical Systems	40	2026-08-13

206 more applicants have LNH clearances. See the full list in Caduvo.

Most recent LNH clearances

510(k)	Applicant	Device	Decision date	Review days
K261758	Aspect Imaging, Ltd.	Embrace Vision Neonatal MRI System	2026-09-16	111
K261283	Fujifilm Corporation	APERTO Lucent MRI System	2026-09-16	152
K260758	Siemens Shenzhen Magnetic Resonance , Ltd.	MAGNETOM Free.Max; MAGNETOM Free.Star	2026-09-01	176
K262622	Hyperfine, Inc.	Swoop® Portable MR Imaging® System	2026-08-19	22
K254250	Xingaoyi Medical Equipment Co.,Ltd	MagicScan-1.5, GreenMR Serenity 1.5T	2026-08-17	231

Recalls for LNH devices

723 product recalls in 189 recall events; 354 initiated in the last five years and 375 still open. Most recent: 2026-08-28.

Year	Recalls
2017	12
2018	89
2019	10
2020	5
2021	83
2022	14
2023	17
2024	122
2025	126
2026	44

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

C8903 — Magnetic resonance imaging with contrast, breast; unilateral
C8906 — Magnetic resonance imaging with contrast, breast; bilateral
C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral
C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral
C8919 — Magnetic resonance angiography without contrast, pelvis

Frequently asked questions

What is FDA product code LNH?

LNH is the FDA product code for system, nuclear magnetic resonance imaging. It is a Class II device, regulated under 21 CFR 892.1000 and reviewed by the Radiology panel.

What device class is LNH?

Class II, regulation 21 CFR 892.1000. Typical premarket route: 510(k).

How long does a 510(k) take for product code LNH?

Across 1,107 cleared submissions the average was 110 days from receipt to decision (median 86).

Which companies have the most LNH 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 (40).

Have LNH devices been recalled?

Yes: 723 product recalls across 189 recall events; the most recent began 2026-08-28.

Next steps

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.

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