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 12, 2004 | K042718 | 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA Siemens Medi Cal Solutions, Inc. | MOS |
| Nov 5, 2004 | K042617 | 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA Siemens Medical Solutions USA, Inc. | MOS |
| Nov 3, 2004 | K042844 | GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL Ge Medical Systems, Inc. | MOS |
| Sep 24, 2004 | K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| Aug 26, 2004 | K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL Usa Instruments, Inc. | MOS |
| Aug 26, 2004 | K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY Usa Instruments, Inc. | MOS |
| Aug 16, 2004 | K042103 | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL Mri Devices Corporation | MOS |
| Aug 11, 2004 | K042009 | MARK III PHASED ARRAY SHOULDER COIL Usa Instruments, Inc. | MOS |
| Jul 26, 2004 | K041921 | GE SIGNA PROFILE 6 INCH GP COIL Ge Medical Systems, LLC | MOS |
| Jul 19, 2004 | K041481 | MODEL BBC-127 BIOPSY BREAST COIL Mri Devices Corp. | MOS |
| Jun 17, 2004 | K041487 | QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT Usa Instruments, Inc. | MOS |
| May 14, 2004 | K041185 | TORSO ARRAY COIL, MODEL 558GE-64 Igc-Medical Advances, Inc. | MOS |
| May 14, 2004 | K041145 | MODIFICATION TO E-SCAN XQ MRI SYSTEM Esaote, S.p.A. | MOS |
| Apr 23, 2004 | K040937 | TEM 3000 HEAD COIL Mr Instruments, Inc. | MOS |
| Apr 14, 2004 | K040122 | MAYO CLINIC BC-10 3.0T Mayo Clinic | MOS |
| Mar 22, 2004 | K040640 | MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL Igc-Medical Advances, Inc. | MOS |
| Mar 9, 2004 | K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL Mri Devices Corp. | MOS |
| Mar 9, 2004 | K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL Mri Devices Corp. | MOS |
| Mar 5, 2004 | K040288 | QSC-127-INT SHOULDER ARRAY COIL SET Mri Devices Corp. | MOS |
| Feb 2, 2004 | K033662 | SYNERGY SPINE ARRAY COIL Philips Medical Systems, Inc. | MOS |
| Jan 9, 2004 | K033490 | SPIRIT 5000 CARDIAC COIL Usa Instruments, Inc. | MOS |
| Dec 17, 2003 | K033753 | PELVIC ARRAY COIL Usa Instruments, Inc. | MOS |
| Dec 17, 2003 | K033235 | GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL Usa Instruments, Inc. | MOS |
| Nov 26, 2003 | K033292 | AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 Igc-Medical Advances, Inc. | MOS |
| Nov 25, 2003 | K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS Mri Devices Corp. | MOS |
| Nov 14, 2003 | K033353 | MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES Usa Instruments, Inc. | MOS |
| Oct 23, 2003 | K032576 | BIOPSY BREAST COIL, MODEL BBC Mri Devices Corp. | MOS |
| Oct 10, 2003 | K033152 | HAC-12 AND HAC-30 HEAD ARRAY COIL Mri Devices Corp. | MOS |
| Oct 10, 2003 | K033151 | KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL Mri Devices Corp. | MOS |
| Sep 25, 2003 | K032633 | HRK-63-8 KNEE ARRAY COIL Mri Devices Corp. | MOS |
| Sep 12, 2003 | K032618 | 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL Usa Instruments, Inc. | MOS |
| Sep 12, 2003 | K032538 | 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL Usa Instruments, Inc. | MOS |
| Aug 25, 2003 | K032474 | 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL Usa Instruments, Inc. | MOS |
| Aug 25, 2003 | K032415 | MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL Usa Instruments, Inc. | MOS |
| Aug 21, 2003 | K032429 | QSC-127 SHOULDER ARRAY COIL SET Mri Devices Corp. | MOS |
| Aug 21, 2003 | K032090 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 Mri Devices Corp. | MOS |
| Jul 30, 2003 | K032045 | 8 CHANNEL CARDIAC PHASED ARRAY COIL GE Medical Systems | MOS |
| Jul 18, 2003 | K031536 | BRAIN COIL, MODEL 9900GE-64 Clinical MR Solutions, LLC | MOS |
| Jul 18, 2003 | K031365 | PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc. | MOS |
| Jul 15, 2003 | K031119 | MAYO CLINIC BC-10 1.5T Mayo Medical Ventures | MOS |
| Jul 11, 2003 | K031366 | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| Jun 20, 2003 | K031095 | SENSE BODY COIL Philips Medical Systems (Cleveland), Inc. | MOS |
| May 29, 2003 | K031172 | SPIRIT III TOTALSENSE CARDIAC COIL Usa Instruments, Inc. | MOS |
| May 29, 2003 | K031143 | ALPHA 5000 WRIST COIL Usa Instruments, Inc. | MOS |
| May 29, 2003 | K031139 | PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| May 23, 2003 | K031209 | GE 1.5T 8 CHANNEL TORSO COIL Ge Medical Systems, Inc. | MOS |
| May 8, 2003 | K031089 | GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY W. L. Gore & Associates, Inc. | MOS |
| May 8, 2003 | K031056 | MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. | MOS |
| May 5, 2003 | K030371 | PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc. | MOS |
| Apr 16, 2003 | K030540 | HTS ARRAY COIL Jockey Club Mri Engineering Center, HK | MOS |
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