LNH · Class II · 21 CFR 892.1000

FDA Product Code LNH: System, Nuclear Magnetic Resonance Imaging

FDA product code LNH covers magnetic resonance imaging (MRI) systems.

These diagnostic imaging systems use strong magnetic fields and radiofrequency pulses to generate detailed cross-sectional images of soft tissue, organs, and musculoskeletal structures without ionizing radiation. MRI is widely used in neurology, oncology, and orthopedics.

LNH devices are Class II medical devices, regulated under 21 CFR 892.1000 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Mri, Inc. and Philips Medical Systems (Cleveland), Inc..

1110

Total

1110

Cleared

110d

Avg days

1988

Since

Stable submission activity - 53 submissions in the last 2 years

Review times increasing: avg 126d recently vs 109d historically

FDA 510(k) Cleared System, Nuclear Magnetic Resonance Imaging Devices (Product Code LNH)

1110 devices

1–24 of 1110

1 2 3 4

SwiftSight-BodyComposition

APERTO Lucent MRI System

Embrace Vision Neonatal MRI System

Siemens Shenzhen Magnetic Resonance , Ltd.

Radiology · 176d

Cleared Aug 19, 2026

Swoop® Portable MR Imaging® System

MagicScan-1.5, GreenMR Serenity 1.5T

K254250

Xingaoyi Medical Equipment Co.,Ltd

Siemens Healthineers AG

Shanghai United Imaging Healthcare Co., Ltd.

Radiology · 128d

Cleared Apr 06, 2026

APERTO Lucent MRI System

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

K253625

Canon Medical Systems Corporation

Radiology · 129d

Cleared Mar 27, 2026

S-scan Open (100001800)

Embrace Neonatal MRI System

LiverMultiScan (v6.0)

Magnifico Open (100009900)

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

K253648

Philips Medical Systems Nederland B.V.

Siemens Shenzhen Magnetic Resonance , Ltd.

Ge Medical Systems, LLC

Ge Medical Systems, LLC

Radiology · 71d

Cleared Jan 26, 2026

Ascent3T Neonatal Magnetic Resonance Imaging System

K253499

Eyas Medical Imaging, Inc.

Radiology · 89d

1 2 3 4

About Product Code LNH - Regulatory Context

510(k) Submission Activity

1110 total 510(k) submissions under product code LNH since 1988, with 1110 receiving FDA clearance (average review time: 110 days).

Submission volume has remained relatively stable over the observed period, with 53 submissions in the last 24 months.

FDA 510(k) Review Time - LNH Product Code

Recent submissions under LNH have taken an average of 126 days to reach a decision - up from 109 days historically. Manufacturers should account for longer review timelines in current project planning.

LNH devices are reviewed by the Radiology panel. Browse all Radiology devices →

FDA Product Code LNH: System, Nuclear Magnetic Resonance Imaging

FDA 510(k) Cleared System, Nuclear Magnetic Resonance Imaging Devices (Product Code LNH)

About Product Code LNH - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - LNH Product Code

Related FDA 510(k) Regulatory Insights