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 3, 2011 | K103149 | 1.5T 16-CHANNEL HAND-WRIST COIL Invivo Corporation | MOS |
| Dec 23, 2010 | K103342 | 3.0T METAFLEXCOIL Neocoil, LLC | MOS |
| Dec 22, 2010 | K102348 | 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T Rapid Biomedical GmbH, DE | MOS |
| Dec 20, 2010 | K102889 | HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON Hitachi Medical Systems America, Inc. | MOS |
| Aug 31, 2010 | K093689 | 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS Mr Medical Solutions, LLC | MOS |
| Aug 27, 2010 | K100141 | 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. | MOS |
| Aug 24, 2010 | K101632 | METAFLEXCOIL Neocoil, LLC | MOS |
| Aug 18, 2010 | K091047 | NEONATE ARRAY COILS Lmt Medical Systems GmbH, DE | MOS |
| Jul 28, 2010 | K101949 | PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 Shanghai Chenguang Medical Technologies Co, Ltd., CN | MOS |
| Jul 14, 2010 | K101858 | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 Shanghai Chenguang Medical Technologies Co, Ltd., CN | MOS |
| Jun 23, 2010 | K101492 | 8 CHANNEL CARDIAC PHASED ARRAY COIL Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Apr 22, 2010 | K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 Sentinelle Medical, Inc., CA | MOS |
| Apr 5, 2010 | K100670 | S-SCAN, MODEL 9800020010 Esaote, S.p.A. | MOS |
| Mar 5, 2010 | K093842 | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS Invivo Corporation | MOS |
| Feb 1, 2010 | K093284 | 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL Invivo Corporation | MOS |
| Jan 28, 2010 | K093667 | SHOULDER SPEEDER COIL Quality Electrodynamics | MOS |
| Jan 19, 2010 | K093693 | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH Noras Mri Products GmbH, DE | MOS |
| Nov 25, 2009 | K093348 | 3.0T 16 CHANNEL HEAD NECK SPINE COIL Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Oct 9, 2009 | K092962 | CAROTID COIL 5000004901 Shanghai Chenguang Medical Technologies Co, Ltd., CN | MOS |
| Aug 21, 2009 | K091902 | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 Invivo | MOS |
| Jun 24, 2009 | K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 Noras Mri Products GmbH, DE | MOS |
| May 1, 2009 | K091114 | TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL Quality Electrodynamics | MOS |
| Apr 3, 2009 | K083539 | INFANT CARDIAC ARRAY Advanced Imaging Research, Inc. | MOS |
| Mar 16, 2009 | K090267 | SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 Midwest Rf, LLC | MOS |
| Feb 24, 2009 | K083541 | NEONATE HEAD AND BODY COILS Advanced Imaging Research, Inc. | MOS |
| Jan 16, 2009 | K083578 | NORAS CPC MULTIFUNCTIONAL COIL Noras Mri Products GmbH, DE | MOS |
| Jan 13, 2009 | K083166 | SPECIALTY COILS FOR THE MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. | MOS |
| Dec 23, 2008 | K083434 | TT1 GENERAL PURPOSE COIL Tursiop Technologies, LLC | MOS |
| Dec 5, 2008 | K083086 | ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) Hitachi Medical Systems America, Inc. | MOS |
| Nov 21, 2008 | K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T Rapid Biomedical GmbH, DE | MOS |
| Nov 7, 2008 | K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL Quality Electrodynamics | MOS |
| Nov 6, 2008 | K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL Invivo | MOS |
| Oct 17, 2008 | K083014 | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A Toshiba America Medical Systems, In.C | MOS |
| Oct 15, 2008 | K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL Invivo | MOS |
| Sep 25, 2008 | K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T Quality Electrodynamics | MOS |
| Aug 29, 2008 | K082373 | NORAS MR-BI320-PA 3T Noras Mri Products GmbH, DE | MOS |
| Aug 12, 2008 | K081745 | ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL Hitachi Medical Systems America, Inc. | MOS |
| Jun 18, 2008 | K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 Shanghai Chenguang Medical Technologies Co, Ltd. | MOS |
| Jun 18, 2008 | K081322 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL Shanghai Chenguang Medical Technologies Co, Ltd. | MOS |
| Jun 18, 2008 | K081198 | ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N Hitachi Medical Systems America, Inc. | MOS |
| May 2, 2008 | K081118 | NORAS MR-BI320-PA 1.5T Noras Mri Products GmbH, DE | MOS |
| Apr 2, 2008 | K080820 | TEM 3002G- HN DUAL TUNE HEAD COIL Mr Instruments, Inc. | MOS |
| Mar 10, 2008 | K080120 | HFO SHOULDER COIL Philips Medical Systems MR Finland | MOS |
| Feb 11, 2008 | K080062 | OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 Hitachi Medical Systems America, Inc. | MOS |
| Jan 18, 2008 | K073310 | OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL Hitachi Medical Corp. | MOS |
| Jan 18, 2008 | K073131 | MICROMRI WRIST COIL Micromri, Inc. | MOS |
| Nov 30, 2007 | K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE Neocoil | MOS |
| Nov 21, 2007 | K073181 | NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL Neocoil, LLC | MOS |
| Nov 16, 2007 | K072874 | LBS-127-16 BREAST ARRAY COIL Invivo | MOS |
| Nov 16, 2007 | K072873 | LBS-63-16 BREAST ARRAY COIL Invivo | MOS |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.