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 |
|---|---|---|---|
| Apr 10, 2003 | K030953 | GE 3.0T GENERAL PURPOSE FLEX COIL Ge Medical Systems, Inc. | MOS |
| Mar 25, 2003 | K030317 | MODEL 1300GE-64: PEDIATRIC POSITIONER Midwest Rf, LLC | MOS |
| Mar 5, 2003 | K030495 | 3.0T TORSO PHASED ARRAY COIL Ge Medical Systems, Inc. | MOS |
| Feb 24, 2003 | K030042 | PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Feb 21, 2003 | K023982 | LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL Usa Instruments, Inc. | MOS |
| Feb 21, 2003 | K023929 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE Advanced Imaging Research, Inc. | MOS |
| Feb 14, 2003 | K023848 | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: Igc-Medical Advances, Inc. | MOS |
| Feb 4, 2003 | K024187 | SPIRIT III TOTALSENSE CARDIAC COIL Usa Instruments, Inc. | MOS |
| Feb 4, 2003 | K022863 | HTS COIL Jockey Club Mri Engineering Center, HK | MOS |
| Jan 24, 2003 | K023650 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL Usa Instruments, Inc. | MOS |
| Jan 9, 2003 | K024354 | PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS Mri Devices Corp. | MOS |
| Jan 9, 2003 | K024352 | HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM Mri Devices Corp. | MOS |
| Jan 9, 2003 | K024209 | QWH-250-PAN WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Jan 7, 2003 | K024208 | OBC-250-PAN BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Dec 23, 2002 | K023247 | CHAMPION 5000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Dec 16, 2002 | K023084 | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL Medical Advances, Inc. | MOS |
| Nov 20, 2002 | K023571 | 6 CHANNEL BODY COIL Siemens Medical Systems, Inc. | MOS |
| Nov 18, 2002 | K023679 | GORE 3.0T TORSO ARRAY W. L. Gore & Associates, Inc. | MOS |
| Nov 8, 2002 | K023596 | MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL Medrad, Inc. | MOS |
| Nov 5, 2002 | K023442 | EXTRA LARGE BODY COIL GE Medical Systems | MOS |
| Nov 4, 2002 | K022007 | LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES Usa Instruments, Inc. | MOS |
| Oct 22, 2002 | K022582 | EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL Usa Instruments, Inc. | MOS |
| Oct 11, 2002 | K023164 | BBC-63-GE BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Oct 3, 2002 | K022910 | QSC-63-INT SHOULDER ARRAY COIL SET Mri Devices Corp. | MOS |
| Sep 27, 2002 | K022883 | HRK-63 KNEE ARRAY COIL Mri Devices Corp. | MOS |
| Sep 6, 2002 | K022720 | CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL Mri Devices Corp. | MOS |
| Sep 6, 2002 | K022669 | 8 CHANNEL CARDIAC PHASED ARRAY COIL GE Medical Systems | MOS |
| Sep 4, 2002 | K022588 | HRW-63-INT WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Aug 23, 2002 | K022488 | MODEL OBC-63 BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Aug 23, 2002 | K022487 | MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL Mri Devices Corp. | MOS |
| Aug 15, 2002 | K021751 | ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc. | MOS |
| Aug 13, 2002 | K022395 | 1.5T SCANMED PV ARRAY Medic, Inc. | MOS |
| Aug 13, 2002 | K022372 | HRH-127-8 HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Aug 13, 2002 | K021631 | ISA-21 INTERVENTIONAL SPINE ARRAY COIL Mri Devices Corp. | MOS |
| Jul 25, 2002 | K021330 | MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL Usa Instruments, Inc. | MOS |
| Jun 27, 2002 | K021141 | MILLENNIUM 5000 MEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| Jun 13, 2002 | K021433 | MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL Medical Advances, Inc. | MOS |
| Jun 12, 2002 | K021575 | OBC-127 BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Jun 12, 2002 | K021570 | HNC-127-TRIO NEUROVASCULAR ARRAY COIL Mri Devices Corp. | MOS |
| Jun 6, 2002 | K020850 | GPF-29 GENERAL PURPOSE COIL SET Mri Devices Corp. | MOS |
| May 21, 2002 | K021262 | MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL Usa Instruments, Inc. | MOS |
| May 21, 2002 | K020993 | ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) Magna-Lab, Inc. | MOS |
| May 21, 2002 | K020790 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL Surgi-Vision, Inc. | MOS |
| Apr 24, 2002 | K020601 | FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL Odin Medical Technologies , Ltd., IL | MOS |
| Apr 23, 2002 | K020495 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL Surgi-Vision, Inc. | MOS |
| Mar 13, 2002 | K020606 | NVA-63-8 NEUROVASCULAR ARRAY COIL Mri Devices Corp. | MOS |
| Feb 6, 2002 | K013854 | MARK 5000 QUADRATURE SHOULDER COIL Usa Instruments, Inc. | MOS |
| Feb 5, 2002 | K014086 | CTL BODY / SPINE ARRAY COIL Usa Instruments, Inc. | MOS |
| Feb 1, 2002 | K020036 | EXS-63 SMALL EXTREMITY ARRAY COIL Mri Devices Corp. | MOS |
| Feb 1, 2002 | K013985 | MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX Machnet BV | MOS |
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