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
217–240 of 490
Cleared Jun 20, 2000
BREAST IMMOBILIZATION DEVICE MR-BY 160
K001303
Mri Devices Corp.
Radiology · 57d
Cleared Jun 14, 2000
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K001713
Mri Devices Corp.
Radiology · 9d
Cleared Jun 09, 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210
Usa Instruments, Inc.
Radiology · 56d
Cleared Jun 09, 2000
SYNERGY HEAD/NECK COIL
K001331
Philips Medical Systems North America, Inc.
Radiology · 43d
Cleared Jun 01, 2000
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
K001209
Usa Instruments, Inc.
Radiology · 48d
Cleared May 26, 2000
LIBERTY 9000 BREAST COIL
K000993
Usa Instruments, Inc.
Radiology · 59d
Cleared Apr 20, 2000
OPART, MODEL MRT-600
K000549
Toshiba America Mri, Inc.
Radiology · 62d
Cleared Apr 14, 2000
INTERVENTIONAL BODY COIL
K000437
Usa Instruments, Inc.
Radiology · 64d
Cleared Apr 11, 2000
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
K000345
Medical Advances, Inc.
Radiology · 68d
Cleared Apr 07, 2000
KFA-63 KNEE AND FOOT ARRAY
K000935
Mri Devices Corp.
Radiology · 15d
Cleared Mar 07, 2000
AIRIS II
K994378
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Feb 23, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000002
Usa Instruments, Inc.
Radiology · 51d
Cleared Feb 14, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K994345
Usa Instruments, Inc.
Radiology · 53d
Cleared Feb 04, 2000
KAC-63 KNEE ARRAY COIL
K993898
Mri Devices Corp.
Radiology · 80d
Cleared Feb 04, 2000
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Jan 31, 2000
SHARP 9000 PHASED ARRAY BRAIN COIL
K994042
Usa Instruments, Inc.
Radiology · 63d
Cleared Jan 18, 2000
PHASED ARRAY KNEE AND FOOT COIL
K994040
Usa Instruments, Inc.
Radiology · 50d
Cleared Dec 03, 1999
OBC-300 BREAST ARRAY COIL
K993776
Mri Devices Corp.
Radiology · 25d
Cleared Dec 03, 1999
QWH-300 WRIST ARRAY COIL
K993819
Mri Devices Corp.
Radiology · 23d
Cleared Nov 26, 1999
KAC-300 KNEE ARRAY COIL
K993719
Mri Devices Corp.
Radiology · 23d
Cleared Nov 26, 1999
QSC-300 SHOULDER ARRAY COILS
K993780
Mri Devices Corp.
Radiology · 18d
Cleared Nov 01, 1999
HRW WRIST ARRAY COIL
K993477
Mri Devices Corp.
Radiology · 18d
Cleared Oct 15, 1999
OBC-085 BREAST ARRAY COIL
K993233
Mri Devices Corp.
Radiology · 18d
Cleared Oct 15, 1999
QWH-085 WRIST ARRAY COIL
K993235
Mri Devices Corp.
Radiology · 18d