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 |
|---|---|---|---|
| Nov 2, 1998 | K982919 | MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC Medrad, Inc. | MOS |
| Oct 29, 1998 | K982916 | MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC Medrad, Inc. | MOS |
| Oct 15, 1998 | K982772 | SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL Ge Medical Systems, Inc. | MOS |
| Oct 8, 1998 | K983222 | PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 Medical Advances, Inc. | MOS |
| Oct 6, 1998 | K983109 | MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY Medical Advances, Inc. | MOS |
| Sep 18, 1998 | K982496 | QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D Medical Advances, Inc. | MOS |
| Sep 4, 1998 | K982339 | FLOW 7000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Jul 31, 1998 | K981959 | OUTLOOK LARGE PHASED ARRAY NECK COIL Philips Medical Systems (Cleveland), Inc. | MOS |
| Jul 16, 1998 | K981406 | CERVIX COIL LATEX SHEATH Philips Medical Systems (Cleveland), Inc. | MOS |
| Jun 18, 1998 | K981094 | MEDRAD NEUROVASCULAR COIL Medrad, Inc. | MOS |
| May 11, 1998 | K980691 | AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. | MOS |
| Apr 30, 1998 | K974438 | MEDRAD ATD-T INTERFACE DEVICE Medrad, Inc. | MOS |
| Apr 13, 1998 | K980157 | PREMIER 7000 CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Jan 27, 1998 | K974308 | MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY Medrad, Inc. | MOS |
| Dec 30, 1997 | K973787 | MEDRAD 1.5T EXTREMITY ARRAY Medrad, Inc. | MOS |
| Dec 5, 1997 | K973630 | CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc. | MOS |
| Sep 15, 1997 | K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) Elscint, Inc. | MOS |
| Sep 15, 1997 | K972296 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM Ge Medical Systems, Inc. | MOS |
| Sep 5, 1997 | K972205 | ALPHA 7000 QUADRATURE WRIST COIL Usa Instruments, Inc. | MOS |
| Aug 21, 1997 | K972340 | INSIGHT 7000 PHASED ARRAY TORSO COIL Usa Instruments, Inc. | MOS |
| Jul 23, 1997 | K971667 | CARDIAC PHASED ARRAY COIL GE Medical Systems | MOS |
| Jun 26, 1997 | K964969 | SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) GE Medical Systems | MOS |
| Jun 20, 1997 | K971246 | LEO 7000 QUADRATURE KNEE COIL Usa Instruments, Inc. | MOS |
| Jun 6, 1997 | K971016 | MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) Hitachi Medical Systems America, Inc. | MOS |
| Jun 6, 1997 | K970868 | MODEL HNC NEUROVASCULAR ARRAY COIL Mri Devices Corp. | MOS |
| Feb 28, 1997 | K964820 | MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A Us Asia Instruments, Inc. | MOS |
| Feb 26, 1997 | K964813 | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: Medical Advances, Inc. | MOS |
| Feb 18, 1997 | K964668 | MODELS EXL AND EXS EXTREMITY COIL SET Mri Devices Corp. | MOS |
| Feb 11, 1997 | K964854 | MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL Medrad, Inc. | MOS |
| Feb 11, 1997 | K964678 | PHASED ARRAY NECK COIL Philips Medical Systems (Cleveland), Inc. | MOS |
| Jan 30, 1997 | K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER Contour Fabricators, Inc. | MOS |
| Nov 22, 1996 | K963356 | PHASED ARRAY SHOULDER COIL Philips Medical Systems (Cleveland), Inc. | MOS |
| Sep 5, 1996 | K961628 | MINI FLEX COIL W. L. Gore & Associates, Inc. | MOS |
| Sep 5, 1996 | K961525 | ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) Mri Devices Corp. | MOS |
| Jul 9, 1996 | K961391 | FLEXART QD HEAD/NECK COIL Toshiba America Mri, Inc. | MOS |
| Mar 13, 1996 | K954952 | MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL Medrad, Inc. | MOS |
| Feb 27, 1996 | K955626 | MEDRAD/HITACHI BREAST IMAGING SURFACE COIL Medrad, Inc. | MOS |
| Nov 20, 1995 | K954190 | MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL Medical Advances, Inc. | MOS |
| Oct 27, 1995 | K953595 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE Medical Systems | MOS |
| Aug 23, 1995 | K952944 | MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL Medical Advances, Inc. | MOS |
| Jul 26, 1995 | K950966 | MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE Medical Advances, Inc. | MOS |
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