FDA Product Code
FDA Product Code LNH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 1,108 records · page 4 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143253 | O-MAR | Philips Medical Systems Nederland B.V. | 2015-04-09 | Traditional | PDF ↗ |
| K143128 | mDIXON XD | Philips Medical Systems Nederlands B.V. | 2015-03-20 | Traditional | PDF ↗ |
| K142734 | TRILLIUM Oval MR System | Hitachi Medical Systems America, Inc. | 2015-03-02 | Traditional | PDF ↗ |
| K143251 | SIGNA Creator, SIGNA Explorer | Ge Healthcare (Ge Medical Systems, LLC) | 2015-02-04 | Traditional | PDF ↗ |
| K141945 | ECHOSTAR COMFORT 1.5T MRI | Alltech Medical Systems America, Inc. | 2015-02-03 | Traditional | PDF ↗ |
| K142997 | RTHawk, HeartVista Workstation with RTHawk | Heartvista, Inc. | 2014-12-17 | Special | PDF ↗ |
| K142361 | Discovery MR750 3.0T | Ge Medical Systems, LLC | 2014-12-05 | Traditional | PDF ↗ |
| K141977 | MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL | Siemens Medical Solutions USA, Inc. | 2014-11-19 | Traditional | PDF ↗ |
| K131737 | SUPERNOVA C5 MRI SYSTEM | Liaoning Kampo Medical System Co., Ltd. | 2014-10-23 | Traditional | PDF ↗ |
| K142515 | MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra | Siemens Medical Solutions USA, Inc. | 2014-10-08 | Special | PDF ↗ |
| K142085 | DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T | Ge Medical Systems, LLC | 2014-09-26 | Traditional | PDF ↗ |
| K141472 | VANTAGE ELAN | Toshiba America Medical Systems, In.C | 2014-09-19 | Traditional | PDF ↗ |
| K140956 | LCD MONITOR | Nordicneurolab | 2014-08-07 | Traditional | PDF ↗ |
| K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE | Neocoil, LLC | 2014-07-24 | Abbreviated | PDF ↗ |
| K133848 | RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK | Heartvista, Inc. | 2014-06-25 | Traditional | PDF ↗ |
| K140666 | MR ELASTOGRAPHY | Philips Medical Systems Nederland B.V. | 2014-06-13 | Traditional | PDF ↗ |
| K132381 | CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT | Clearmri Solutions, Inc. | 2014-04-04 | Traditional | PDF ↗ |
| K140253 | MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE | Siemens Medical Solutions USA, Inc. | 2014-03-20 | Traditional | PDF ↗ |
| K131896 | SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM | Suzhou Anke Medical System Co., Ltd. | 2014-02-28 | Traditional | PDF ↗ |
| K133526 | MDIXON-QUANT | Philips Medical Systems Nederland B.V. | 2014-02-12 | Traditional | PDF ↗ |
| K133692 | IMRI 1.5T AND IMRI 3T S | Imris, Inc. | 2014-02-10 | Traditional | PDF ↗ |
| K130692 | M2 WRIST 2 MRI SYSTEM | Aspect Imaging, Ltd. | 2014-01-14 | Traditional | PDF ↗ |
| K133490 | G-SCAN BRIO | Esaote, S.p.A. | 2013-12-30 | Special | PDF ↗ |
| K131996 | S-SCAN | Esaote, S.p.A. | 2013-12-13 | Special | PDF ↗ |
| K122035 | HEPAFAT SCAN | Resonance Health Analysis Services Pty, Ltd. | 2013-12-13 | Traditional | PDF ↗ |
| K133435 | MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A | Siemens Medical Solutions USA, Inc. | 2013-12-12 | Special | PDF ↗ |
| K132119 | MAGNETOM PRISMA, MAGNETOM PRISMA FIT | Siemens Medical Solutions USA, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T | Ge Healthcare (Ge Medical Systems, LLC) | 2013-11-15 | Traditional | PDF ↗ |
| K132951 | MAGNETOM AERA | Siemens Medical Solutions USA, Inc. | 2013-11-15 | Special | PDF ↗ |
| K132831 | QUIET/SILENT SCANNING SUITE | Siemens Medical Solutions USA, Inc. | 2013-11-01 | Traditional | PDF ↗ |
| K132160 | VANTAGE TITAN 3T | Toshibamedical Systems Corporation | 2013-10-16 | Traditional | PDF ↗ |
| K131241 | SWIP | Philips Medical Systems Nederland B.V. | 2013-08-30 | Traditional | PDF ↗ |
| K130658 | ELIXBO PM545 | Xbo Medical Systems Co., Ltd. | 2013-07-19 | Traditional | PDF ↗ |
| K130115 | DISCOVERY MR750W 3.0T | Ge Medical Systems, LLC | 2013-05-23 | Traditional | PDF ↗ |
| K123510 | MAGNETOM SKYRA | Siemens Medical Solutions USA, Inc. | 2013-05-17 | Traditional | PDF ↗ |
| K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT | Siemens Medical Solutions USA, Inc. | 2013-05-17 | Traditional | PDF ↗ |
| K123522 | OPTIMA MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013-03-13 | Traditional | PDF ↗ |
| K130262 | MAGNETOM ESSENZA WITH SYNGO MR D14 | Siemens Medical Solutions USA, Inc. | 2013-03-01 | Special | PDF ↗ |
| K123938 | SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN | Siemens Medical Solutions USA, Inc. | 2013-02-12 | Traditional | PDF ↗ |
| K120701 | M2 WRIST MRI SYSTEM | Aspect Imaging, Ltd. | 2013-02-07 | Traditional | PDF ↗ |
| K123417 | BRIVO MR355, OPTIMA MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2013-01-17 | Traditional | PDF ↗ |
| K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US | Toshiba America Medical Systems, In.C | 2012-12-13 | Traditional | PDF ↗ |
| K113394 | MAVRIC SL | Ge Medical Systems, LLC | 2012-12-11 | Traditional | PDF ↗ |
| K122034 | MRJ 3300 | Paramed S.R.L. | 2012-12-06 | Special | PDF ↗ |
| K123068 | OPTIMA MR 430S | Ge Medical Systems, LLC | 2012-11-13 | Special | PDF ↗ |
| K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO | Siemens Medi Cal Solutions, Inc. | 2012-11-05 | Traditional | PDF ↗ |
| K122026 | PRISM ACQUIRE PRISM PROCESS PRISM VIEW | Prism Clinical Imaging, Inc. | 2012-09-21 | Special | PDF ↗ |
| K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT | Ge Medical Systems, LLC | 2012-09-20 | Traditional | PDF ↗ |
| K121997 | IMRIS ONCOLOGY PACKAGE | Imris, Inc. | 2012-08-10 | Traditional | PDF ↗ |
| K122006 | G-SCAN BRIO | Esaote, S.p.A. | 2012-08-06 | Special | PDF ↗ |
| K121160 | MAGNETOM SPECTRA | Siemens Medical Solutions USA, Inc. | 2012-07-16 | Traditional | PDF ↗ |
| K121650 | S-SCAN | Esaote, S.p.A. | 2012-07-09 | Special | PDF ↗ |
| K121545 | BELLYBOARD, SBRT ACCESSORIES | Medtec Inc. Dba Civco Medical Solutions | 2012-06-08 | Traditional | PDF ↗ |
| K120638 | VANTAGE TITAN | Toshibamedical Systems Corporation | 2012-06-01 | Traditional | PDF ↗ |
| K121239 | MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE | Optoacoustics, Ltd. | 2012-05-24 | Traditional | PDF ↗ |
| K120487 | VANTAGE TITAN 3T | Toshibamedical Systems Corporation | 2012-05-23 | Traditional | PDF ↗ |
| K113281 | MRI SYTEMS | Shenzhen Anke High-Tech Co., Ltd. | 2012-05-17 | Traditional | PDF ↗ |
| K113511 | ECHOSTAR SPICA 1.5T MR SYSTEM | Alltech Medical Systems America, Inc. | 2012-05-02 | Traditional | PDF ↗ |
| K113145 | ECHELON OVAL MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2012-05-01 | Traditional | PDF ↗ |
| K120748 | SPEEDUP SOFTWARE OPTION | Esaote, S.p.A. | 2012-05-01 | Traditional | PDF ↗ |
| K120778 | BRIVO MR355 | Ge Hangwei Medical Systems Co., Ltd. | 2012-03-27 | Special | PDF ↗ |
| K113093 | VANTAGE TITAN 3T | Toshibamedical Systems Corporation | 2012-01-13 | Traditional | PDF ↗ |
| K113490 | OPTIMA MR450W | Ge Medical Systems, LLC | 2012-01-13 | Traditional | PDF ↗ |
| K113337 | VISIA DYNAMIC REVIEW | MeVis Medical Solutions AG | 2011-12-30 | Traditional | PDF ↗ |
| K112003 | VANTAGE TITAN HSR | Toshibamedical Systems Corporation | 2011-12-02 | Traditional | PDF ↗ |
| K111242 | MAGNETOM AERA AND MAGNETOM SKYRA | Siemens Medical Solutions USA, Inc. | 2011-11-23 | Traditional | PDF ↗ |
| K103327 | DISCOVERY MR750W 3.0T | Ge Healthcare Japan Corporation | 2011-09-30 | Traditional | PDF ↗ |
| K102489 | VANTAGE TITAN 3T | Toshiba Medical Systems Corporation, Japan | 2011-08-02 | Traditional | PDF ↗ |
| K110942 | PICA WHOLE-BODY MRI SYSTEM | Time Medical Limited | 2011-07-26 | Abbreviated | PDF ↗ |
| K111803 | G-SCAN | Esaote, S.p.A. | 2011-07-15 | Special | PDF ↗ |
| K111226 | ENDOSCOUT TRACKING SYSTEM | Robin Medical, Inc. | 2011-07-01 | Special | PDF ↗ |
| K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM | Medtec, Inc. | 2011-06-28 | Traditional | PDF ↗ |
| K110802 | A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 | Esaote, S.p.A. | 2011-04-08 | Special | PDF ↗ |
| K103411 | IDEAL IQ SOFTWARE OPTION | GE Medical Systems | 2011-03-22 | Traditional | PDF ↗ |
| K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T | Philips Health Care | 2011-03-22 | Traditional | PDF ↗ |
| K110238 | G-SCAN | Esaote, S.p.A. | 2011-02-17 | Special | PDF ↗ |
| K103330 | BRIVO MR355, OPTIMA MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2011-02-11 | Traditional | PDF ↗ |
| K103238 | 1.5T OPTIMA MR430S | Ge Medical Systems, LLC | 2011-02-11 | Traditional | PDF ↗ |
| K103507 | MEDICAL VISORS MV100 | Medical Visors, Inc. | 2011-02-08 | Traditional | PDF ↗ |
| K102344 | MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS | Philips Medical Systems Nederland B.V. | 2010-11-09 | Traditional | PDF ↗ |
| K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO | Imris, Inc. | 2010-10-05 | Traditional | PDF ↗ |
| K101347 | MAGNETOM AERA; MAGNETOM SKYRA | Siemens Medical Solutions USA, Inc. | 2010-10-01 | Traditional | PDF ↗ |
| K102155 | MR RADIATION ONCOLOGY OPTIONS | Ge Medical Systems, LLC | 2010-08-31 | Special | PDF ↗ |
| K101295 | MROPEN | Paramed S.R.L. | 2010-07-28 | Traditional | PDF ↗ |
| K093738 | MRI PATIENT POSITIONING DEVICES | Medtec, Inc. | 2010-05-14 | Traditional | PDF ↗ |
| K100164 | MR INSPIRE WITH EXTENDED KIT | Paramed S.R.L. | 2010-04-05 | Special | PDF ↗ |
| K093984 | PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 | Time Medical Limited | 2010-03-24 | Special | PDF ↗ |
| K092308 | POLESTAR, MODEL N-30 | Medtronic Navigation Israel, Ltd. | 2010-03-16 | Traditional | PDF ↗ |
| K100352 | DIAGNOSOFT HARP MODEL 2.06 | Diagnosoft, Inc. | 2010-03-11 | Special | PDF ↗ |
| K093336 | INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM | Medical Numerics, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K092925 | 3D ASL | Ge Medical Systems, LLC | 2010-01-06 | Traditional | PDF ↗ |
| K092469 | O-SCAN MR SYSTEM | Esaote, S.p.A. | 2009-12-23 | Traditional | PDF ↗ |
| K092230 | MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 | Time Medical Limited | 2009-11-25 | Traditional | PDF ↗ |
| K092899 | OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 | Ningbo Xingaoyi Magnetism Co., Ltd. | 2009-11-10 | Traditional | PDF ↗ |
| K092253 | MODIFICATION TO FMRI HARDWARE SYSTEM | Nordicneurolab | 2009-10-08 | Special | PDF ↗ |
| K092237 | NSM-S15 SYSTEM | Neusoft Medical Systems Co., Ltd. | 2009-09-09 | Traditional | PDF ↗ |
| K091166 | IMRX | Imris, Inc. | 2009-09-02 | Traditional | PDF ↗ |
| K083421 | MR-TOUCH OPTION | Ge Medical Systems, LLC | 2009-07-24 | Traditional | PDF ↗ |
| K091580 | PICA WHOLE BODY MRI SYSTEM | Time Medical Limited | 2009-07-24 | Traditional | PDF ↗ |
| K091444 | PERFSCAPE | Olea Medical | 2009-07-20 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.