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