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