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
169–192 of 490
Cleared Jun 27, 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141
Usa Instruments, Inc.
Radiology · 79d
Cleared Jun 13, 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433
Medical Advances, Inc.
Radiology · 38d
Cleared Jun 12, 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
OBC-127 BREAST ARRAY COIL
K021575
Mri Devices Corp.
Radiology · 29d
Cleared Jun 06, 2002
GPF-29 GENERAL PURPOSE COIL SET
K020850
Mri Devices Corp.
Radiology · 83d
Cleared May 21, 2002
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
K021262
Usa Instruments, Inc.
Radiology · 29d
Cleared Mar 13, 2002
NVA-63-8 NEUROVASCULAR ARRAY COIL
K020606
Mri Devices Corp.
Radiology · 16d
Cleared Feb 06, 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854
Usa Instruments, Inc.
Radiology · 78d
Cleared Feb 05, 2002
CTL BODY / SPINE ARRAY COIL
K014086
Usa Instruments, Inc.
Radiology · 56d
Cleared Feb 01, 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036
Mri Devices Corp.
Radiology · 28d
Cleared Jan 22, 2002
BODY ARRAY COIL
K013594
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 22, 2002
PREMIER III PHASED ARRAY CTL SPINE COIL
K013595
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 18, 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894
Philips Medical Systems North America, Inc.
Radiology · 56d
Cleared Jan 08, 2002
EXTREMITY COIL
K013592
Usa Instruments, Inc.
Radiology · 70d
Cleared Jan 02, 2002
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514
Mri Devices Corp.
Radiology · 72d
Cleared Dec 14, 2001
SHOULDER COIL
K013541
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 13, 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 10, 2001
NURVO 9000 ENDOCAVITARY COILS
K011683
Usa Instruments, Inc.
Radiology · 194d
Cleared Nov 27, 2001
CARDIOVASCULAR ARRAY
K013810
W.L. Gore & Associates, Inc.
Radiology · 12d
Cleared Nov 20, 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508
Mri Devices Corp.
Radiology · 29d
Cleared Nov 20, 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602
Mri Devices Corp.
Radiology · 20d
Cleared Oct 16, 2001
HRH-63-8 HEAD ARRAY COIL
K013159
Mri Devices Corp.
Radiology · 25d
Cleared Oct 16, 2001
HAC-420 HEAD ARRAY COIL
K013322
Mri Devices Corp.
Radiology · 11d
Cleared Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099
Mri Devices Corp.
Radiology · 8d