Coil, Magnetic Resonance, Specialty
Regulation 892.1000
10510(k)s in 12 months (491 all time)
0recalls in 12 months (38 all time)
37recalls that name a 510(k)
Top companies in MOS
| Company | 510(k)s | Recalls |
|---|---|---|
| Usa Instruments, Inc. | 63 | 2 |
| Mri Devices Corp. | 65 | 0 |
| Quality Electrodynamics | 33 | 9 |
| Invivo | 21 | 2 |
| Hitachi Medical Systems America, Inc. | 18 | 3 |
| GE Medical Systems | 19 | 1 |
| Neocoil | 18 | 2 |
| Medical Advances, Inc. | 19 | 0 |
| Medrad, Inc. | 18 | 0 |
| Philips North America Llc | 0 | 16 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2002 | K013595 | PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Jan 22, 2002 | K013594 | BODY ARRAY COIL Usa Instruments, Inc. | MOS |
| Jan 18, 2002 | K013894 | TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T Philips Medical Systems North America, Inc. | MOS |
| Jan 8, 2002 | K013592 | EXTREMITY COIL Usa Instruments, Inc. | MOS |
| Jan 2, 2002 | K013514 | PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL Mri Devices Corp. | MOS |
| Dec 14, 2001 | K013541 | SHOULDER COIL Usa Instruments, Inc. | MOS |
| Dec 13, 2001 | K013528 | CRYSTAL 5000 PHASES ARRAY TMJ COIL Usa Instruments, Inc. | MOS |
| Dec 10, 2001 | K011683 | NURVO 9000 ENDOCAVITARY COILS Usa Instruments, Inc. | MOS |
| Nov 27, 2001 | K013810 | CARDIOVASCULAR ARRAY W. L. Gore & Associates, Inc. | MOS |
| Nov 20, 2001 | K013602 | HNC-63-INT NEUROVASCULAR ARRAY COIL Mri Devices Corp. | MOS |
| Nov 20, 2001 | K013508 | HRH-127-ALLEGRA HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Oct 24, 2001 | K012491 | MACHNET CAROTIDS COIL ARRAY ASSEMBLY Machnet BV | MOS |
| Oct 16, 2001 | K013322 | HAC-420 HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Oct 16, 2001 | K013159 | HRH-63-8 HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Sep 25, 2001 | K013099 | MODIFICATION TO: QWH-420 WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Aug 31, 2001 | K011781 | INTERCEPT-URETHRAL MICROCOIL Surgi-Vision, Inc. | MOS |
| Aug 29, 2001 | K012728 | E-SCAN MRI SYSTEM Biosound Esaote, Inc. | MOS |
| Aug 14, 2001 | K012353 | HNC-127 NEUROVASCULAR ARRAY COIL Mri Devices Corp. | MOS |
| Aug 14, 2001 | K011608 | MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL Medical Advances, Inc. | MOS |
| Jun 8, 2001 | K010802 | CARDIAC VIEW, MODEL 2001 Magna Lab, Inc. | MOS |
| May 30, 2001 | K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. | MOS |
| May 25, 2001 | K003505 | KFA-127 KNEE, FOOT AND ANKLE ARRAY Mri Devices Corp. | MOS |
| May 21, 2001 | K010513 | CARDIAC VIEW, MODEL 2001 Magna-Lab, Inc. | MOS |
| May 16, 2001 | K010730 | MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Apr 3, 2001 | K010074 | MODEL 455GE PHASED ARRAY WRIST COIL Medical Advances, Inc. | MOS |
| Apr 3, 2001 | K003613 | 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL GE Medical Systems | MOS |
| Feb 27, 2001 | K003946 | SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE Medical Systems | MOS |
| Feb 22, 2001 | K010140 | HRH-127 HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Feb 2, 2001 | K003655 | PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL Mri Devices Corp. | MOS |
| Feb 2, 2001 | K003436 | SURGI-VISION GUIDEWIRE COIL Surgi-Vision, Inc. | MOS |
| Jan 18, 2001 | K001097 | ACTIVE ARRAY CATHETER, MODEL CS-2000 Image-Guided Neurologics, Inc. | MOS |
| Dec 28, 2000 | K003386 | SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 Midwest Rf, LLC | MOS |
| Dec 28, 2000 | K003097 | BRAIN COIL, MODEL 9800GE-64 Midwest Rf, LLC | MOS |
| Dec 22, 2000 | K003685 | MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL Medical Advances, Inc. | MOS |
| Dec 22, 2000 | K003366 | MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL Igc-Medical Advances, Inc. | MOS |
| Dec 13, 2000 | K003144 | MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL Medical Advances, Inc. | MOS |
| Nov 28, 2000 | K002916 | SURGI-VISION PROSTATE COIL Surgi-Vision, Inc. | MOS |
| Nov 22, 2000 | K002860 | MODEL 6900GE-64: C-SPINE ARRAY Midwest Rf, LLC | MOS |
| Nov 21, 2000 | K002864 | MODEL 6600GE-64: TRAMA NECK ARRAY Midwest Rf, LLC | MOS |
| Nov 16, 2000 | K002774 | HRH-63 HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Nov 8, 2000 | K003340 | OBC-149 BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Nov 8, 2000 | K003331 | QWH-149 WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Oct 25, 2000 | K002522 | OPART, MODEL MRT-600 Toshiba America Mri, Inc. | MOS |
| Oct 25, 2000 | K002483 | POWER 5000 GENERAL PURPOSE COIL Usa Instruments, Inc. | MOS |
| Oct 17, 2000 | K002482 | VISION 9000 PHASED ARRAY TORSO COIL Usa Instruments, Inc. | MOS |
| Oct 11, 2000 | K002345 | SURGI-VISION URETHRAL COIL Surgi-Vision, Inc. | MOS |
| Sep 5, 2000 | K002602 | OBC-63 MEBREAST ARRAY COIL Mri Devices Corp. | MOS |
| Aug 30, 2000 | K002539 | OBC-096 BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Aug 30, 2000 | K001946 | NEUROVASCULAR ARRAY COIL Ge Medical Systems, Inc. | MOS |
| Aug 14, 2000 | K001944 | HAC-300 HEAD ARRAY COIL Mri Devices Corp. | MOS |
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