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
97–120 of 490
Cleared Jun 28, 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728
Usa Instruments, Inc.
Radiology · 99d
Cleared Jun 23, 2005
3.0T PROSTATE IMAGING SYSTEM
K051349
Medrad, Inc.
Radiology · 30d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307
Hitachi Medical Systems America, Inc.
Radiology · 20d
Cleared Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617
Siemens Medical Solutions USA, Inc.
Radiology · 42d
Cleared Nov 03, 2004
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
K042844
Ge Medical Systems, Inc.
Radiology · 19d
Cleared Sep 24, 2004
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
K042342
Usa Instruments, Inc.
Radiology · 25d
Cleared Aug 26, 2004
3.0T 8-CHANNEL CTL SPINE ARRAY
K042186
Usa Instruments, Inc.
Radiology · 14d
Cleared Aug 26, 2004
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
K042207
Usa Instruments, Inc.
Radiology · 10d
Cleared Aug 11, 2004
MARK III PHASED ARRAY SHOULDER COIL
K042009
Usa Instruments, Inc.
Radiology · 16d
Cleared Jul 26, 2004
GE SIGNA PROFILE 6 INCH GP COIL
K041921
Ge Medical Systems, LLC
Radiology · 10d
Cleared Jul 19, 2004
MODEL BBC-127 BIOPSY BREAST COIL
K041481
Mri Devices Corp.
Radiology · 46d
Cleared Jun 17, 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K041487
Usa Instruments, Inc.
Radiology · 13d
Cleared May 14, 2004
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K041145
Esaote, S.P.A.
Radiology · 11d
Cleared Mar 09, 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349
Mri Devices Corp.
Radiology · 26d
Cleared Mar 05, 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288
Mri Devices Corp.
Radiology · 28d
Cleared Feb 02, 2004
SYNERGY SPINE ARRAY COIL
K033662
Philips Medical Systems, Inc.
Radiology · 73d
Cleared Jan 09, 2004
SPIRIT 5000 CARDIAC COIL
K033490
Usa Instruments, Inc.
Radiology · 66d
Cleared Dec 17, 2003
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
K033235
Usa Instruments, Inc.
Radiology · 72d
Cleared Dec 17, 2003
PELVIC ARRAY COIL
K033753
Usa Instruments, Inc.
Radiology · 16d
Cleared Nov 25, 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K033567
Mri Devices Corp.
Radiology · 15d
Cleared Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353
Usa Instruments, Inc.
Radiology · 25d
Cleared Oct 23, 2003
BIOPSY BREAST COIL, MODEL BBC
K032576
Mri Devices Corp.
Radiology · 64d
Cleared Oct 10, 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K033151
Mri Devices Corp.
Radiology · 10d