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 Canon Medical Systems Corporation, Siemens Medical Solutions USA, Inc. and Shanghai United Imaging Healthcare Co., Ltd..
FDA 510(k) Cleared System, Nuclear Magnetic Resonance Imaging Devices (Product Code LNH)
About Product Code LNH - Regulatory Context
510(k) Submission Activity
1098 total 510(k) submissions under product code LNH since 1988, with 1098 receiving FDA clearance (average review time: 110 days).
Submission volume has remained relatively stable over the observed period, with 50 submissions in the last 24 months.
FDA Review Time
FDA review times for LNH submissions have been consistent, averaging 124 days recently vs 109 days historically.
LNH devices are reviewed by the Radiology panel. Browse all Radiology devices →