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
145–168 of 490
Cleared Jan 24, 2003
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
K023650
Usa Instruments, Inc.
Radiology · 86d
Cleared Jan 09, 2003
QWH-250-PAN WRIST ARRAY COIL
K024209
Mri Devices Corp.
Radiology · 20d
Cleared Jan 09, 2003
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K024352
Mri Devices Corp.
Radiology · 10d
Cleared Jan 09, 2003
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
K024354
Mri Devices Corp.
Radiology · 10d
Cleared Jan 07, 2003
OBC-250-PAN BREAST ARRAY COIL
K024208
Mri Devices Corp.
Radiology · 18d
Cleared Dec 23, 2002
CHAMPION 5000 PERIPHERAL VASCULAR COIL
K023247
Usa Instruments, Inc.
Radiology · 84d
Cleared Dec 16, 2002
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K023084
Medical Advances, Inc.
Radiology · 90d
Cleared Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679
W.L. Gore & Associates, Inc.
Radiology · 17d
Cleared Nov 08, 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K023596
Medrad, Inc.
Radiology · 11d
Cleared Nov 05, 2002
EXTRA LARGE BODY COIL
K023442
GE Medical Systems
Radiology · 21d
Cleared Nov 04, 2002
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K022007
Usa Instruments, Inc.
Radiology · 138d
Cleared Oct 22, 2002
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
K022582
Usa Instruments, Inc.
Radiology · 78d
Cleared Oct 11, 2002
BBC-63-GE BREAST ARRAY COIL
K023164
Mri Devices Corp.
Radiology · 18d
Cleared Oct 03, 2002
QSC-63-INT SHOULDER ARRAY COIL SET
K022910
Mri Devices Corp.
Radiology · 30d
Cleared Sep 27, 2002
HRK-63 KNEE ARRAY COIL
K022883
Mri Devices Corp.
Radiology · 28d
Cleared Sep 06, 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669
GE Medical Systems
Radiology · 25d
Cleared Sep 06, 2002
CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
K022720
Mri Devices Corp.
Radiology · 22d
Cleared Sep 04, 2002
HRW-63-INT WRIST ARRAY COIL
K022588
Mri Devices Corp.
Radiology · 30d
Cleared Aug 23, 2002
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488
Mri Devices Corp.
Radiology · 25d
Cleared Aug 15, 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751
Hitachi Medical Systems America, Inc.
Radiology · 79d
Cleared Aug 13, 2002
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K021631
Mri Devices Corp.
Radiology · 88d
Cleared Aug 13, 2002
HRH-127-8 HEAD ARRAY COIL
K022372
Mri Devices Corp.
Radiology · 22d
Cleared Jul 25, 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330
Usa Instruments, Inc.
Radiology · 90d