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
169–192 of 490
Cleared Aug 18, 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950
Hitachi Medical Systems America, Inc.
Radiology · 39d
Cleared May 05, 2006
OR HEAD COIL 1.5 T
K060758
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Mar 15, 2006
MEDRAD 3.0T ECOIL IMAGING SYSTEM
K060401
Medrad, Inc.
Radiology · 28d
Cleared Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042
Medrad, Inc.
Radiology · 20d
Cleared Nov 16, 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
K053017
Invivo Corporation
Radiology · 21d
Cleared Nov 09, 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916
Usa Instruments, Inc.
Radiology · 23d
Cleared Nov 01, 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827
Medrad, Inc.
Radiology · 27d
Cleared Oct 07, 2005
1.5T 12 CHANNEL BODY ARRAY
K052584
Usa Instruments, Inc.
Radiology · 17d
Cleared Oct 07, 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621
Usa Instruments, Inc.
Radiology · 14d
Cleared Oct 04, 2005
3T HD BREAST ARRAY
K052585
Usa Instruments, Inc.
Radiology · 14d
Cleared Aug 16, 2005
G-SCAN CERVICAL SPINE COIL
K052077
Esaote, S.P.A.
Radiology · 15d
Cleared Aug 02, 2005
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
K051618
Midwest Rf, LLC
Radiology · 46d
Cleared Jul 14, 2005
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 28, 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728
Usa Instruments, Inc.
Radiology · 99d
Cleared Jun 28, 2005
CAC-127-8 CARDOAC ARRAY COIL
K051512
Invivo Corp.
Radiology · 21d
Cleared Jun 23, 2005
3.0T PROSTATE IMAGING SYSTEM
K051349
Medrad, Inc.
Radiology · 30d
Cleared Apr 08, 2005
HRW-63-8 WRIST ARRAY COIL
K050622
Mri Devices Corporation
Radiology · 29d
Cleared Apr 07, 2005
NVA-127-8-A NEUROVASCULAR ARRAY COIL
K050621
Mri Devices Corporation
Radiology · 28d
Cleared Mar 25, 2005
CORDLESS COIL
K050476
Siemens Medical Solution, Inc. USA
Radiology · 29d
Cleared Mar 25, 2005
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
K050514
Mri Devices Corporation
Radiology · 24d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307
Hitachi Medical Systems America, Inc.
Radiology · 20d
Cleared Feb 24, 2005
HRK-123 KNEE ARRAY COIL
K050299
Mri Devices Corporation
Radiology · 17d
Cleared Nov 12, 2004
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
K042718
Siemens Medi Cal Solutions, Inc.
Radiology · 43d
Cleared Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617
Siemens Medical Solutions USA, Inc.
Radiology · 42d