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 Quality Electrodynamics, LLC.

490
Total
490
Cleared
63d
Avg days
1995
Since
490 devices
361–384 of 490
Cleared Nov 02, 1998
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
K982919
Medrad, Inc.
Radiology · 75d
Cleared Oct 29, 1998
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
K982916
Medrad, Inc.
Radiology · 71d
Cleared Oct 15, 1998
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
K982772
Ge Medical Systems, Inc.
Radiology · 69d
Cleared Oct 08, 1998
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K983222
Medical Advances, Inc.
Radiology · 23d
Cleared Oct 06, 1998
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY
K983109
Medical Advances, Inc.
Radiology · 32d
Cleared Sep 18, 1998
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
K982496
Medical Advances, Inc.
Radiology · 63d
Cleared Sep 04, 1998
FLOW 7000 PERIPHERAL VASCULAR COIL
K982339
Usa Instruments, Inc.
Radiology · 60d
Cleared Jul 31, 1998
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959
Philips Medical Systems (Cleveland), Inc.
Radiology · 57d
Cleared Jul 16, 1998
CERVIX COIL LATEX SHEATH
K981406
Philips Medical Systems (Cleveland), Inc.
Radiology · 87d
Cleared Jun 18, 1998
MEDRAD NEUROVASCULAR COIL
K981094
Medrad, Inc.
Radiology · 84d
Cleared May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared Apr 30, 1998
MEDRAD ATD-T INTERFACE DEVICE
K974438
Medrad, Inc.
Radiology · 157d
Cleared Apr 13, 1998
PREMIER 7000 CTL SPINE COIL
K980157
Usa Instruments, Inc.
Radiology · 87d
Cleared Jan 27, 1998
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
K974308
Medrad, Inc.
Radiology · 71d
Cleared Dec 30, 1997
MEDRAD 1.5T EXTREMITY ARRAY
K973787
Medrad, Inc.
Radiology · 85d
Cleared Dec 05, 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K973630
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Sep 15, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972296
Ge Medical Systems, Inc.
Radiology · 88d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592
Elscint, Inc.
Radiology · 66d
Cleared Sep 05, 1997
ALPHA 7000 QUADRATURE WRIST COIL
K972205
Usa Instruments, Inc.
Radiology · 85d
Cleared Aug 21, 1997
INSIGHT 7000 PHASED ARRAY TORSO COIL
K972340
Usa Instruments, Inc.
Radiology · 58d
Cleared Jul 23, 1997
CARDIAC PHASED ARRAY COIL
K971667
GE Medical Systems
Radiology · 78d
Cleared Jun 26, 1997
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K964969
GE Medical Systems
Radiology · 196d
Cleared Jun 20, 1997
LEO 7000 QUADRATURE KNEE COIL
K971246
Usa Instruments, Inc.
Radiology · 78d
Cleared Jun 06, 1997
MODEL HNC NEUROVASCULAR ARRAY COIL
K970868
Mri Devices Corp.
Radiology · 88d