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