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 |
|---|---|---|---|
| May 8, 2014 | K140252 | 16 CH MULTIPURPOSE COIL VARIETY Noras Rontgen-Und Medizintechnik GmbH, DE | MOS |
| Feb 26, 2014 | K140282 | ST SENSE NV 8 ARRAY COIL Resonance Innovations, LLC | MOS |
| Jan 27, 2014 | K133986 | 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY Resonance Innovations, LLC | MOS |
| Jan 27, 2014 | K132444 | ATAMA SYSTEM Monteris Medical, | MOS |
| Dec 26, 2013 | K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE Neocoil, LLC | MOS |
| Jul 25, 2013 | K130706 | DUOFLEX COIL SUITE (1.5T) Mr Instruments, Inc. | MOS |
| May 20, 2013 | K130457 | 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL Resonance Innovations, LLC | MOS |
| Apr 10, 2013 | K123708 | SPINE COIL Usa Paramed Medical Systems, Inc. | MOS |
| Mar 28, 2013 | K123272 | 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM Neocoil, LLC | MOS |
| Feb 22, 2013 | K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL Wipro GE Healthcare Private, Ltd., IN | MOS |
| Jan 11, 2013 | K123327 | 1.5T GEM RT OPEN ARRAY Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Dec 27, 2012 | K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T Imris, Inc., CA | MOS |
| Dec 21, 2012 | K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 Invivo Corporation | MOS |
| Dec 13, 2012 | K123492 | DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) Philips Medical Systems | MOS |
| Nov 2, 2012 | K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T Invivo Corporation | MOS |
| Oct 25, 2012 | K122694 | GE 8CH FOOT ANKLE COIL Ge Hangwei Medical Systems Co., Ltd. | MOS |
| Sep 25, 2012 | K122638 | TOSHIBA 3T 32CH HEAD SPEEDER COIL, Quality Electrodynamics | MOS |
| Aug 17, 2012 | K121911 | OCTAVE SPEEDER SPINE Toshiba Medical Systems Corporation, Japan | MOS |
| Aug 17, 2012 | K121910 | OCTAVE SPEEDER HEAD Toshiba Medical Systems Corporation, Japan | MOS |
| Jun 15, 2012 | K121362 | 1.5T 16CH FLEX SPEEDER LARGE Neocoil, LLC | MOS |
| Jun 12, 2012 | K121249 | MULTIARRAY KIT Paramed S.R.L., IT | MOS |
| Mar 29, 2012 | K120627 | TOSHIBA 1.5T QD HEAD COIL Quality Electrodynamics | MOS |
| Mar 29, 2012 | K113365 | INFANT ARRAY Advanced Imaging Research Dba Sree Medical Systems | MOS |
| Mar 16, 2012 | K113474 | 1.5T GEM FLEX COIL Neocoil, LLC | MOS |
| Feb 28, 2012 | K120290 | TOSHIBA 1.5T CARDIAC COIL Quality Electrodynamics | MOS |
| Feb 10, 2012 | K120122 | SENSE MSK S 8CH 1.5T Invivo Corporation | MOS |
| Dec 23, 2011 | K111673 | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL Invivo Corporation | MOS |
| Nov 23, 2011 | K113280 | CAROTID COIL GE 1.5T Tursiop Technologies, LLC | MOS |
| Nov 18, 2011 | K112002 | CAROTID COIL Shanghai Chenguang Medical Technologies Co, Ltd., CN | MOS |
| Sep 30, 2011 | K112293 | HTS EXTREMITY COIL, HTS SURFACE COIL Time Medical Systems, Inc., CN | MOS |
| Sep 15, 2011 | K112366 | 4CH FLEX SPEEDER Toshiba Medical Systems Coporation, Japan | MOS |
| Sep 9, 2011 | K112313 | TOSHIBA 3T EXTRA LARGE KNEE COIL Quality Electrodynamics | MOS |
| Sep 9, 2011 | K111060 | MRGFUS PELVIC PA COIL MODEL 1.0 Insightech, Ltd., IL | MOS |
| Sep 8, 2011 | K111802 | SV BRAIN ARRAY, SIEMENS 3T Mri Interventions, Inc. | MOS |
| Aug 25, 2011 | K112112 | SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS Sentinel Medical, Inc., CA | MOS |
| Aug 18, 2011 | K103274 | SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING Sentinelle Medical, Inc., CA | MOS |
| Jul 5, 2011 | K111259 | SV DBS VRAIN ARRAY Midwest Rf, LLC | MOS |
| May 27, 2011 | K111251 | 4CH FLEX SPEEDER Toshiba Medical Systems Coporation, Japan | MOS |
| May 13, 2011 | K102748 | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T Rapid Biomedical GmbH, DE | MOS |
| Apr 19, 2011 | K110487 | FLEXIBLE CARDIAC COIL Lbds Holding Company | MOS |
| Apr 8, 2011 | K110411 | ATAMA SYSTEM Monteris Medical, Inc., CA | MOS |
| Apr 6, 2011 | K110373 | TEMPOROMANIBULAR COIL 15 Esaote, S.p.A., IT | MOS |
| Apr 1, 2011 | K110610 | 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL Ge Medical Systems, LLC | MOS |
| Mar 29, 2011 | K110591 | MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL Mr Instruments, Inc. | MOS |
| Mar 7, 2011 | K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS GE Healthcare | MOS |
| Feb 25, 2011 | K110120 | ECHELON RAPID CARDIAC COIL Hitachi Medical Systems America, Inc. | MOS |
| Feb 25, 2011 | K103185 | TOSHIBA 1.5T EXTRA LARGE KNEE COIL Quality Electrodynamics | MOS |
| Feb 2, 2011 | K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) Imris, Inc. | MOS |
| Jan 12, 2011 | K103365 | DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Jan 11, 2011 | K103275 | SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS Siemens Medical Solutions USA, Inc. | MOS |
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