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