MOS · Class II · 21 CFR 892.1000

FDA Product Code MOS: Coil, Magnetic Resonance, Specialty

Specialized MRI coils optimize image quality for specific anatomical regions. FDA product code MOS covers specialty magnetic resonance coils used in clinical and research MRI applications.

These surface, phased array, or volume coils are placed close to the anatomy of interest to improve signal-to-noise ratio and spatial resolution for dedicated applications including cardiac, breast, extremity, and neurovascular MRI.

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

Leading manufacturers include Usa Instruments, Inc., Mri Devices Corp. and Medical Advances, Inc..

490
Total
490
Cleared
63d
Avg days
1995
Since
490 devices
241–264 of 490
Cleared Oct 15, 1999
QSC-085 SHOULDER ARRAY COIL
K993279
Mri Devices Corp.
Radiology · 15d
Cleared Oct 08, 1999
AIRIS, AIRIS II
K992650
Hitachi Medical Systems America, Inc.
Radiology · 63d
Cleared Aug 02, 1999
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
K991724
Medical Advances, Inc.
Radiology · 74d
Cleared Aug 02, 1999
OPART, MODEL MRT-600
K991740
Toshiba America Mri, Inc.
Radiology · 73d
Cleared Aug 02, 1999
SYNERGY SHOULDER COIL
K991765
Philips Medical Systems North America, Inc.
Radiology · 70d
Cleared Jul 06, 1999
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434
Medical Advances, Inc.
Radiology · 71d
Cleared Jun 10, 1999
`INEAR WRIST COIL, MODEL 440GE-09
K991113
Medical Advances, Inc.
Radiology · 70d
Cleared Jun 08, 1999
LINEAR SHOULDER COIL, MODEL 414GE-09
K991115
Medical Advances, Inc.
Radiology · 68d
Cleared May 20, 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057
Toshiba America Mri, Inc.
Radiology · 51d
Cleared Apr 01, 1999
OPART, MODEL MRT-600
K990007
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Feb 19, 1999
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K983139
GE Medical Systems
Radiology · 164d
Cleared Feb 08, 1999
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588
Philips Medical Systems (Cleveland), Inc.
Radiology · 46d
Cleared Jan 25, 1999
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
K984257
Medrad, Inc.
Radiology · 56d
Cleared Jan 12, 1999
MEDRAD QUADRATURE CTL ARRAY COIL
K984159
Medrad, Inc.
Radiology · 54d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
K984272
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
K984278
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Nov 23, 1998
MODEL 340GE-21C QUADRATURE BRAIN COIL
K982978
Medical Advances, Inc.
Radiology · 90d
Cleared Nov 16, 1998
SIGNA PROFILE SMALL HEAD COIL
K982972
GE Medical Systems
Radiology · 83d
Cleared Nov 16, 1998
MARK 5000 PHASED ARRAY SHOULDER COIL
K983143
Usa Instruments, Inc.
Radiology · 69d
Cleared Nov 03, 1998
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K982921
Medrad, Inc.
Radiology · 76d
Cleared Nov 02, 1998
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
K982919
Medrad, Inc.
Radiology · 75d
Cleared Oct 29, 1998
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
K982916
Medrad, Inc.
Radiology · 71d
Cleared Oct 15, 1998
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
K982772
Ge Medical Systems, Inc.
Radiology · 69d
Cleared Oct 08, 1998
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K983222
Medical Advances, Inc.
Radiology · 23d