FDA Product Code
FDA Product Code MOS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 490 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140282 | ST SENSE NV 8 ARRAY COIL | Resonance Innovations, LLC | 2014-02-26 | Special | PDF ↗ |
| K132444 | ATAMA SYSTEM | Monteris Medical, | 2014-01-27 | Traditional | PDF ↗ |
| K133986 | 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY | Resonance Innovations, LLC | 2014-01-27 | Traditional | PDF ↗ |
| K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE | Neocoil, LLC | 2013-12-26 | Abbreviated | PDF ↗ |
| K130706 | DUOFLEX COIL SUITE (1.5T) | Mr Instruments, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K130457 | 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL | Resonance Innovations, LLC | 2013-05-20 | Special | PDF ↗ |
| K123708 | SPINE COIL | Usa Paramed Medical Systems, Inc. | 2013-04-10 | Traditional | PDF ↗ |
| K123272 | 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM | Neocoil, LLC | 2013-03-28 | Abbreviated | PDF ↗ |
| K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL | Wipro GE Healthcare Private, Ltd. | 2013-02-22 | Traditional | PDF ↗ |
| K123327 | 1.5T GEM RT OPEN ARRAY | Ge Healthcare Coils (Usa Instruments, Inc.) | 2013-01-11 | Traditional | PDF ↗ |
| K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T | Imris, Inc. | 2012-12-27 | Traditional | PDF ↗ |
| K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 | Invivo Corporation | 2012-12-21 | Traditional | PDF ↗ |
| K123492 | DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) | Philips Medical Systems | 2012-12-13 | Special | PDF ↗ |
| K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T | Invivo Corporation | 2012-11-02 | Traditional | PDF ↗ |
| K122694 | GE 8CH FOOT ANKLE COIL | Ge Hangwei Medical Systems Co., Ltd. | 2012-10-25 | Traditional | PDF ↗ |
| K122638 | TOSHIBA 3T 32CH HEAD SPEEDER COIL, | Quality Electrodynamics | 2012-09-25 | Traditional | PDF ↗ |
| K121911 | OCTAVE SPEEDER SPINE | Toshiba Medical Systems Corporation, Japan | 2012-08-17 | Special | PDF ↗ |
| K121910 | OCTAVE SPEEDER HEAD | Toshiba Medical Systems Corporation, Japan | 2012-08-17 | Special | PDF ↗ |
| K121362 | 1.5T 16CH FLEX SPEEDER LARGE | Neocoil, LLC | 2012-06-15 | Traditional | PDF ↗ |
| K121249 | MULTIARRAY KIT | Paramed S.R.L. | 2012-06-12 | Special | PDF ↗ |
| K113365 | INFANT ARRAY | Advanced Imaging Research Dba Sree Medical Systems | 2012-03-29 | Traditional | PDF ↗ |
| K120627 | TOSHIBA 1.5T QD HEAD COIL | Quality Electrodynamics | 2012-03-29 | Traditional | PDF ↗ |
| K113474 | 1.5T GEM FLEX COIL | Neocoil, LLC | 2012-03-16 | Abbreviated | PDF ↗ |
| K120290 | TOSHIBA 1.5T CARDIAC COIL | Quality Electrodynamics | 2012-02-28 | Traditional | PDF ↗ |
| K120122 | SENSE MSK S 8CH 1.5T | Invivo Corporation | 2012-02-10 | Special | PDF ↗ |
| K111673 | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL | Invivo Corporation | 2011-12-23 | Traditional | PDF ↗ |
| K113280 | CAROTID COIL GE 1.5T | Tursiop Technologies, LLC | 2011-11-23 | Traditional | PDF ↗ |
| K112002 | CAROTID COIL | Shanghai Chenguang Medical Technologies Co, Ltd. | 2011-11-18 | Traditional | PDF ↗ |
| K112293 | HTS EXTREMITY COIL, HTS SURFACE COIL | Time Medical Systems, Inc. | 2011-09-30 | Abbreviated | PDF ↗ |
| K112366 | 4CH FLEX SPEEDER | Toshiba Medical Systems Coporation, Japan | 2011-09-15 | Special | PDF ↗ |
| K112313 | TOSHIBA 3T EXTRA LARGE KNEE COIL | Quality Electrodynamics | 2011-09-09 | Special | PDF ↗ |
| K111060 | MRGFUS PELVIC PA COIL MODEL 1.0 | Insightech, Ltd. | 2011-09-09 | Special | PDF ↗ |
| K111802 | SV BRAIN ARRAY, SIEMENS 3T | Mri Interventions, Inc. | 2011-09-08 | Traditional | PDF ↗ |
| K112112 | SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS | Sentinel Medical, Inc. | 2011-08-25 | Special | PDF ↗ |
| K103274 | SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING | Sentinelle Medical, Inc. | 2011-08-18 | Traditional | PDF ↗ |
| K111259 | SV DBS VRAIN ARRAY | Midwest Rf, LLC | 2011-07-05 | Traditional | PDF ↗ |
| K111251 | 4CH FLEX SPEEDER | Toshiba Medical Systems Coporation, Japan | 2011-05-27 | Special | PDF ↗ |
| K102748 | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T | Rapid Biomedical GmbH | 2011-05-13 | Abbreviated | PDF ↗ |
| K110487 | FLEXIBLE CARDIAC COIL | Lbds Holding Company | 2011-04-19 | Traditional | PDF ↗ |
| K110411 | ATAMA SYSTEM | Monteris Medical, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K110373 | TEMPOROMANIBULAR COIL 15 | Esaote, S.p.A. | 2011-04-06 | Traditional | PDF ↗ |
| K110610 | 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL | Ge Medical Systems, LLC | 2011-04-01 | Special | PDF ↗ |
| K110591 | MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL | Mr Instruments, Inc. | 2011-03-29 | Traditional | PDF ↗ |
| K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS | GE Healthcare | 2011-03-07 | Traditional | PDF ↗ |
| K103185 | TOSHIBA 1.5T EXTRA LARGE KNEE COIL | Quality Electrodynamics | 2011-02-25 | Traditional | PDF ↗ |
| K110120 | ECHELON RAPID CARDIAC COIL | Hitachi Medical Systems America, Inc. | 2011-02-25 | Abbreviated | PDF ↗ |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | Imris, Inc. | 2011-02-02 | Traditional | PDF ↗ |
| 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.) | 2011-01-12 | Traditional | PDF ↗ |
| K103275 | SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS | Siemens Medical Solutions USA, Inc. | 2011-01-11 | Traditional | PDF ↗ |
| K103149 | 1.5T 16-CHANNEL HAND-WRIST COIL | Invivo Corporation | 2011-01-03 | Traditional | PDF ↗ |
| K103342 | 3.0T METAFLEXCOIL | Neocoil, LLC | 2010-12-23 | Traditional | PDF ↗ |
| 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 | 2010-12-22 | Abbreviated | PDF ↗ |
| K102889 | HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON | Hitachi Medical Systems America, Inc. | 2010-12-20 | Traditional | PDF ↗ |
| K093689 | 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS | Mr Medical Solutions, LLC | 2010-08-31 | Traditional | PDF ↗ |
| K100141 | 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA | Siemens Medical Solutions USA, Inc. | 2010-08-27 | Traditional | PDF ↗ |
| K101632 | METAFLEXCOIL | Neocoil, LLC | 2010-08-24 | Traditional | PDF ↗ |
| K091047 | NEONATE ARRAY COILS | Lmt Medical Systems GmbH | 2010-08-18 | Traditional | PDF ↗ |
| K101949 | PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010-07-28 | Traditional | PDF ↗ |
| K101858 | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010-07-14 | Traditional | PDF ↗ |
| K101492 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | Ge Healthcare Coils (Usa Instruments, Inc.) | 2010-06-23 | Traditional | PDF ↗ |
| K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 | Sentinelle Medical, Inc. | 2010-04-22 | Special | PDF ↗ |
| K100670 | S-SCAN, MODEL 9800020010 | Esaote, S.p.A. | 2010-04-05 | Special | PDF ↗ |
| K093842 | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS | Invivo Corporation | 2010-03-05 | Traditional | PDF ↗ |
| K093284 | 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL | Invivo Corporation | 2010-02-01 | Traditional | PDF ↗ |
| K093667 | SHOULDER SPEEDER COIL | Quality Electrodynamics | 2010-01-28 | Traditional | PDF ↗ |
| K093693 | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH | Noras Mri Products GmbH | 2010-01-19 | Traditional | PDF ↗ |
| K093348 | 3.0T 16 CHANNEL HEAD NECK SPINE COIL | Ge Healthcare Coils (Usa Instruments, Inc.) | 2009-11-25 | Traditional | PDF ↗ |
| K092962 | CAROTID COIL 5000004901 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2009-10-09 | Traditional | PDF ↗ |
| K091902 | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 | Invivo | 2009-08-21 | Traditional | PDF ↗ |
| K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 | Noras Mri Products GmbH | 2009-06-24 | Special | PDF ↗ |
| K091114 | TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL | Quality Electrodynamics | 2009-05-01 | Traditional | PDF ↗ |
| K083539 | INFANT CARDIAC ARRAY | Advanced Imaging Research, Inc. | 2009-04-03 | Traditional | PDF ↗ |
| K090267 | SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 | Midwest Rf, LLC | 2009-03-16 | Traditional | PDF ↗ |
| K083541 | NEONATE HEAD AND BODY COILS | Advanced Imaging Research, Inc. | 2009-02-24 | Traditional | PDF ↗ |
| K083578 | NORAS CPC MULTIFUNCTIONAL COIL | Noras Mri Products GmbH | 2009-01-16 | Abbreviated | PDF ↗ |
| K083166 | SPECIALTY COILS FOR THE MAGNETOM ESSENZA | Siemens Medical Solutions USA, Inc. | 2009-01-13 | Traditional | PDF ↗ |
| K083434 | TT1 GENERAL PURPOSE COIL | Tursiop Technologies, LLC | 2008-12-23 | Traditional | PDF ↗ |
| K083086 | ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) | Hitachi Medical Systems America, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T | Rapid Biomedical GmbH | 2008-11-21 | Traditional | PDF ↗ |
| K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL | Quality Electrodynamics | 2008-11-07 | Traditional | PDF ↗ |
| K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL | Invivo | 2008-11-06 | Special | PDF ↗ |
| K083014 | ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A | Toshiba America Medical Systems, In.C | 2008-10-17 | Traditional | PDF ↗ |
| K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL | Invivo | 2008-10-15 | Special | PDF ↗ |
| K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T | Quality Electrodynamics | 2008-09-25 | Traditional | PDF ↗ |
| K082373 | NORAS MR-BI320-PA 3T | Noras Mri Products GmbH | 2008-08-29 | Abbreviated | PDF ↗ |
| 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. | 2008-08-12 | Traditional | PDF ↗ |
| K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 | Traditional | PDF ↗ |
| K081198 | ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N | Hitachi Medical Systems America, Inc. | 2008-06-18 | Traditional | PDF ↗ |
| K081322 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 | Traditional | PDF ↗ |
| K081118 | NORAS MR-BI320-PA 1.5T | Noras Mri Products GmbH | 2008-05-02 | Traditional | PDF ↗ |
| K080820 | TEM 3002G- HN DUAL TUNE HEAD COIL | Mr Instruments, Inc. | 2008-04-02 | Traditional | PDF ↗ |
| K080120 | HFO SHOULDER COIL | Philips Medical Systems MR Finland | 2008-03-10 | Traditional | PDF ↗ |
| K080062 | OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 | Hitachi Medical Systems America, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K073310 | OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL | Hitachi Medical Corp. | 2008-01-18 | Abbreviated | PDF ↗ |
| K073131 | MICROMRI WRIST COIL | Micromri, Inc. | 2008-01-18 | Traditional | PDF ↗ |
| K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE | Neocoil | 2007-11-30 | Traditional | PDF ↗ |
| K073181 | NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL | Neocoil, LLC | 2007-11-21 | Traditional | PDF ↗ |
| K072873 | LBS-63-16 BREAST ARRAY COIL | Invivo | 2007-11-16 | Special | PDF ↗ |
| K072874 | LBS-127-16 BREAST ARRAY COIL | Invivo | 2007-11-16 | Special | PDF ↗ |
| K072935 | SPEEDER 1.5T WRIST ARRAY COIL | Quality Electrodynamics | 2007-10-31 | Traditional | PDF ↗ |
Product code MOS · Class II · Radiology. Data: openFDA.