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
193–216 of 490
Cleared Aug 14, 2001
MODEL 235GE-64
K011608
Medical Advances, Inc.
Radiology · 81d
Cleared Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353
Mri Devices Corp.
Radiology · 20d
Cleared May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946
Usa Instruments, Inc.
Radiology · 62d
Cleared May 25, 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505
Mri Devices Corp.
Radiology · 193d
Cleared May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730
Usa Instruments, Inc.
Radiology · 65d
Cleared Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613
GE Medical Systems
Radiology · 132d
Cleared Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074
Medical Advances, Inc.
Radiology · 84d
Cleared Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946
GE Medical Systems
Radiology · 68d
Cleared Feb 22, 2001
HRH-127 HEAD ARRAY COIL
K010140
Mri Devices Corp.
Radiology · 36d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655
Mri Devices Corp.
Radiology · 67d
Cleared Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685
Medical Advances, Inc.
Radiology · 22d
Cleared Dec 13, 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K003144
Medical Advances, Inc.
Radiology · 64d
Cleared Nov 16, 2000
HRH-63 HEAD ARRAY COIL
K002774
Mri Devices Corp.
Radiology · 71d
Cleared Nov 08, 2000
QWH-149 WRIST ARRAY COIL
K003331
Mri Devices Corp.
Radiology · 15d
Cleared Nov 08, 2000
OBC-149 BREAST ARRAY COIL
K003340
Mri Devices Corp.
Radiology · 14d
Cleared Oct 25, 2000
POWER 5000 GENERAL PURPOSE COIL
K002483
Usa Instruments, Inc.
Radiology · 72d
Cleared Oct 25, 2000
OPART, MODEL MRT-600
K002522
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482
Usa Instruments, Inc.
Radiology · 64d
Cleared Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
K002602
Mri Devices Corp.
Radiology · 15d
Cleared Aug 30, 2000
NEUROVASCULAR ARRAY COIL
K001946
Ge Medical Systems, Inc.
Radiology · 65d
Cleared Aug 30, 2000
OBC-096 BREAST ARRAY COIL
K002539
Mri Devices Corp.
Radiology · 14d
Cleared Aug 14, 2000
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
K001870
Usa Instruments, Inc.
Radiology · 55d
Cleared Aug 14, 2000
HAC-300 HEAD ARRAY COIL
K001944
Mri Devices Corp.
Radiology · 49d
Cleared Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582
Usa Instruments, Inc.
Radiology · 56d