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
Aug 14, 2001
MODEL 235GE-64
Medical Advances, Inc.
Radiology
81d
Cleared
Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
Mri Devices Corp.
Radiology
20d
Cleared
May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
Usa Instruments, Inc.
Radiology
62d
Cleared
May 25, 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
Mri Devices Corp.
Radiology
193d
Cleared
May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
Usa Instruments, Inc.
Radiology
65d
Cleared
Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
GE Medical Systems
Radiology
132d
Cleared
Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
Medical Advances, Inc.
Radiology
84d
Cleared
Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
GE Medical Systems
Radiology
68d
Cleared
Feb 22, 2001
HRH-127 HEAD ARRAY COIL
Mri Devices Corp.
Radiology
36d
Cleared
Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
Mri Devices Corp.
Radiology
67d
Cleared
Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
Medical Advances, Inc.
Radiology
22d
Cleared
Dec 13, 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
Medical Advances, Inc.
Radiology
64d
Cleared
Nov 16, 2000
HRH-63 HEAD ARRAY COIL
Mri Devices Corp.
Radiology
71d
Cleared
Nov 08, 2000
QWH-149 WRIST ARRAY COIL
Mri Devices Corp.
Radiology
15d
Cleared
Nov 08, 2000
OBC-149 BREAST ARRAY COIL
Mri Devices Corp.
Radiology
14d
Cleared
Oct 25, 2000
POWER 5000 GENERAL PURPOSE COIL
Usa Instruments, Inc.
Radiology
72d
Cleared
Oct 25, 2000
OPART, MODEL MRT-600
Toshiba America Mri, Inc.
Radiology
71d
Cleared
Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
Usa Instruments, Inc.
Radiology
64d
Cleared
Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
Mri Devices Corp.
Radiology
15d
Cleared
Aug 30, 2000
NEUROVASCULAR ARRAY COIL
Ge Medical Systems, Inc.
Radiology
65d
Cleared
Aug 30, 2000
OBC-096 BREAST ARRAY COIL
Mri Devices Corp.
Radiology
14d
Cleared
Aug 14, 2000
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
Usa Instruments, Inc.
Radiology
55d
Cleared
Aug 14, 2000
HAC-300 HEAD ARRAY COIL
Mri Devices Corp.
Radiology
49d
Cleared
Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
Usa Instruments, Inc.
Radiology
56d