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 |
|---|---|---|---|
| Aug 14, 2000 | K001870 | MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| Jul 17, 2000 | K001582 | LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE Usa Instruments, Inc. | MOS |
| Jun 20, 2000 | K001312 | MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL Igc-Medical Advances, Inc. | MOS |
| Jun 20, 2000 | K001303 | BREAST IMMOBILIZATION DEVICE MR-BY 160 Mri Devices Corp. | MOS |
| Jun 14, 2000 | K001713 | HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA Mri Devices Corp. | MOS |
| Jun 9, 2000 | K001331 | SYNERGY HEAD/NECK COIL Philips Medical Systems North America, Inc. | MOS |
| Jun 9, 2000 | K001210 | HI-RES 9000 PHASED ARRAY CAROTID COIL Usa Instruments, Inc. | MOS |
| Jun 1, 2000 | K001209 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL Usa Instruments, Inc. | MOS |
| May 26, 2000 | K000993 | LIBERTY 9000 BREAST COIL Usa Instruments, Inc. | MOS |
| Apr 20, 2000 | K000549 | OPART, MODEL MRT-600 Toshiba America Mri, Inc. | MOS |
| Apr 14, 2000 | K000437 | INTERVENTIONAL BODY COIL Usa Instruments, Inc. | MOS |
| Apr 11, 2000 | K000345 | MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES Medical Advances, Inc. | MOS |
| Apr 7, 2000 | K000935 | KFA-63 KNEE AND FOOT ARRAY Mri Devices Corp. | MOS |
| Mar 14, 2000 | K994436 | SURGI-VISION ESOPHAGEAL STYLET COIL Surgi-Vision, Inc. | MOS |
| Mar 14, 2000 | K000589 | MODEL 445SI-64E QUADRATURE WRIST COIL Igc-Medical Advances, Inc. | MOS |
| Mar 7, 2000 | K994378 | AIRIS II Hitachi Medical Systems America, Inc. | MOS |
| Feb 23, 2000 | K000002 | MAGNA 5000 PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Feb 14, 2000 | K994345 | MAGNA 5000 PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Feb 4, 2000 | K994315 | CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc. | MOS |
| Feb 4, 2000 | K993898 | KAC-63 KNEE ARRAY COIL Mri Devices Corp. | MOS |
| Jan 31, 2000 | K994042 | SHARP 9000 PHASED ARRAY BRAIN COIL Usa Instruments, Inc. | MOS |
| Jan 18, 2000 | K994040 | PHASED ARRAY KNEE AND FOOT COIL Usa Instruments, Inc. | MOS |
| Dec 3, 1999 | K993819 | QWH-300 WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Dec 3, 1999 | K993776 | OBC-300 BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Nov 26, 1999 | K993780 | QSC-300 SHOULDER ARRAY COILS Mri Devices Corp. | MOS |
| Nov 26, 1999 | K993719 | KAC-300 KNEE ARRAY COIL Mri Devices Corp. | MOS |
| Nov 1, 1999 | K993477 | HRW WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Oct 15, 1999 | K993279 | QSC-085 SHOULDER ARRAY COIL Mri Devices Corp. | MOS |
| Oct 15, 1999 | K993235 | QWH-085 WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Oct 15, 1999 | K993233 | OBC-085 BREAST ARRAY COIL Mri Devices Corp. | MOS |
| Oct 8, 1999 | K992650 | AIRIS, AIRIS II Hitachi Medical Systems America, Inc. | MOS |
| Sep 3, 1999 | K992193 | ENDO-ESOPHAGEAL MR COIL Surgi-Vision, Inc. | MOS |
| Aug 2, 1999 | K991765 | SYNERGY SHOULDER COIL Philips Medical Systems North America, Inc. | MOS |
| Aug 2, 1999 | K991740 | OPART, MODEL MRT-600 Toshiba America Mri, Inc. | MOS |
| Aug 2, 1999 | K991724 | QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 Medical Advances, Inc. | MOS |
| Jul 6, 1999 | K991434 | QUADRATURE WRIST COIL, MODEL 445PH-64 Medical Advances, Inc. | MOS |
| Jun 10, 1999 | K991113 | `INEAR WRIST COIL, MODEL 440GE-09 Medical Advances, Inc. | MOS |
| Jun 8, 1999 | K991115 | LINEAR SHOULDER COIL, MODEL 414GE-09 Medical Advances, Inc. | MOS |
| May 20, 1999 | K991057 | EXTRA LARGE BODY COIL FOR OPART (MRT-600) Toshiba America Mri, Inc. | MOS |
| Apr 1, 1999 | K990007 | OPART, MODEL MRT-600 Toshiba America Mri, Inc. | MOS |
| Feb 19, 1999 | K983139 | SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL GE Medical Systems | MOS |
| Feb 8, 1999 | K984588 | PHASED ARRAY FLEXIBLE CARDIAC COIL Philips Medical Systems (Cleveland), Inc. | MOS |
| Jan 25, 1999 | K984257 | MEDRAD PHASED ARRAY NEUROVASCULAR COIL Medrad, Inc. | MOS |
| Jan 12, 1999 | K984159 | MEDRAD QUADRATURE CTL ARRAY COIL Medrad, Inc. | MOS |
| Dec 11, 1998 | K984278 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II Hitachi Medical Systems America, Inc. | MOS |
| Dec 11, 1998 | K984272 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 Hitachi Medical Systems America, Inc. | MOS |
| Nov 23, 1998 | K982978 | MODEL 340GE-21C QUADRATURE BRAIN COIL Medical Advances, Inc. | MOS |
| Nov 16, 1998 | K983143 | MARK 5000 PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. | MOS |
| Nov 16, 1998 | K982972 | SIGNA PROFILE SMALL HEAD COIL GE Medical Systems | MOS |
| Nov 3, 1998 | K982921 | MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA Medrad, Inc. | MOS |
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