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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
721–744 of 1101
Cleared Nov 20, 1990
ADVANCED C- SPINE COIL
K904327
Toshiba America Mri, Inc.
Radiology · 61d
Cleared Oct 26, 1990
CAT. #6000-21 VOLUME NECK COIL, MODIFIED
K903753
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED
K903754
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 26, 1990
CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED
K903755
Medical Advances, Inc.
Radiology · 94d
Cleared Oct 23, 1990
GYROSCAN S15/ACS
K902799
Philips Medical Systems, Inc.
Radiology · 118d
Cleared Oct 01, 1990
MODEL 4500-SMS-42
K903822
Medical Advances, Inc.
Radiology · 42d
Cleared Sep 27, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
K903527
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Sep 21, 1990
TEMPOROMANDIBULAR JOINT (TMJ) COIL
K902217
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Sep 20, 1990
GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP
K902663
General Electric Co.
Radiology · 94d
Cleared Sep 10, 1990
GYREX 2T VERSION 2.1U.
K903028
Elscint, Inc.
Radiology · 61d
Cleared Aug 30, 1990
VISTA MR 2055 HP SYSTEM
K903048
Philips Medical Systems (Cleveland), Inc.
Radiology · 50d
Cleared Aug 23, 1990
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933
General Electric Co.
Radiology · 51d
Cleared Aug 17, 1990
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
K901952
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Aug 17, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K903319
GE Medical Systems
Radiology · 23d
Cleared Aug 10, 1990
PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
K901888
Medrad, Inc.
Radiology · 106d
Cleared Aug 03, 1990
LARGE FLEXIBLE BODY COIL
K902314
Toshiba America Mri, Inc.
Radiology · 72d
Cleared Aug 01, 1990
SOFTWARE RELEASE 4.2P, ACCESS(TM)
K902310
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
CERVICAL COIL MRT 50A
K902315
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
KNEE QD COIL MRT 50A
K902316
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Jul 06, 1990
GE SIGNA ADVANTAGE
K901730
GE Medical Systems
Radiology · 81d
Cleared May 31, 1990
MODEL 4050-21
K901864
Medical Advances, Inc.
Radiology · 36d
Cleared May 23, 1990
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
K901818
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 14, 1990
MODEL 4050-64
K901639
Medical Advances, Inc.
Radiology · 35d
Cleared Apr 26, 1990
MODEL 2121-64
K901242
Medical Advances, Inc.
Radiology · 42d