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
121–144 of 490
Cleared Oct 10, 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
K033152
Mri Devices Corp.
Radiology · 10d
Cleared Sep 25, 2003
HRK-63-8 KNEE ARRAY COIL
K032633
Mri Devices Corp.
Radiology · 30d
Cleared Sep 12, 2003
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
K032538
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 12, 2003
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
K032618
Usa Instruments, Inc.
Radiology · 17d
Cleared Aug 25, 2003
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
K032415
Usa Instruments, Inc.
Radiology · 20d
Cleared Aug 25, 2003
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
K032474
Usa Instruments, Inc.
Radiology · 13d
Cleared Aug 21, 2003
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
K032090
Mri Devices Corp.
Radiology · 45d
Cleared Aug 21, 2003
QSC-127 SHOULDER ARRAY COIL SET
K032429
Mri Devices Corp.
Radiology · 15d
Cleared Jul 30, 2003
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045
GE Medical Systems
Radiology · 28d
Cleared Jul 18, 2003
PRIMA III TOTALSENSE TORSO COIL
K031365
Usa Instruments, Inc.
Radiology · 79d
Cleared Jul 11, 2003
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
K031366
Usa Instruments, Inc.
Radiology · 72d
Cleared Jun 20, 2003
SENSE BODY COIL
K031095
Philips Medical Systems (Cleveland), Inc.
Radiology · 74d
Cleared May 29, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K031139
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
ALPHA 5000 WRIST COIL
K031143
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K031172
Usa Instruments, Inc.
Radiology · 45d
Cleared May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
K031209
Ge Medical Systems, Inc.
Radiology · 36d
Cleared May 08, 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K031056
Usa Instruments, Inc.
Radiology · 35d
Cleared May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089
W.L. Gore & Associates, Inc.
Radiology · 31d
Cleared May 05, 2003
PRIMA III TOTALSENSE TORSO COIL
K030371
Usa Instruments, Inc.
Radiology · 90d
Cleared Apr 10, 2003
GE 3.0T GENERAL PURPOSE FLEX COIL
K030953
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Mar 05, 2003
3.0T TORSO PHASED ARRAY COIL
K030495
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Feb 24, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K030042
Usa Instruments, Inc.
Radiology · 49d
Cleared Feb 21, 2003
LEO III TX/RX QUADRATURE KNEE COIL
K023982
Usa Instruments, Inc.
Radiology · 81d
Cleared Feb 04, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K024187
Usa Instruments, Inc.
Radiology · 47d