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
289–312 of 490
Cleared Feb 11, 1997
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854
Medrad, Inc.
Radiology · 70d
Cleared Nov 22, 1996
PHASED ARRAY SHOULDER COIL
K963356
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Sep 05, 1996
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525
Mri Devices Corp.
Radiology · 136d
Cleared Sep 05, 1996
MINI FLEX COIL
K961628
W.L. Gore & Associates, Inc.
Radiology · 132d
Cleared Jul 09, 1996
FLEXART QD HEAD/NECK COIL
K961391
Toshiba America Mri, Inc.
Radiology · 90d
Cleared Mar 13, 1996
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
K954952
Medrad, Inc.
Radiology · 135d
Cleared Feb 27, 1996
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
K955626
Medrad, Inc.
Radiology · 78d
Cleared Nov 20, 1995
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K954190
Medical Advances, Inc.
Radiology · 75d
Cleared Oct 27, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K953595
GE Medical Systems
Radiology · 88d
Cleared Aug 23, 1995
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
K952944
Medical Advances, Inc.
Radiology · 58d
Cleared Jul 26, 1995
MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE
K950966
Medical Advances, Inc.
Radiology · 146d