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 5 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091536 | OPTIMA MR450W | Ge Medical Systems, LLC | 2009-07-17 | Traditional | PDF ↗ |
| K091669 | OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III | Xioao Mdt Technology Co, Ltd. | 2009-06-18 | Traditional | PDF ↗ |
| K090038 | SYNGO BREVIS | Siemens Medical Solutions USA, Inc. | 2009-04-28 | Traditional | PDF ↗ |
| K090873 | I OPEN 0.5T | Beijing Wandong Medical Equipment Co., Ltd. | 2009-04-10 | Traditional | PDF ↗ |
| K090433 | I_OPEN 0.4T | Beijing Wandong Medical Equipment Co., Ltd. | 2009-03-25 | Traditional | PDF ↗ |
| K090080 | CIRRUS OPEN | Mri-Tech Sp. Zo.O. | 2009-03-23 | Traditional | PDF ↗ |
| K082964 | PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) | Prism Clinical Imaging, Inc. | 2009-03-09 | Traditional | PDF ↗ |
| K083533 | ECHELON C MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2009-02-17 | Traditional | PDF ↗ |
| K083137 | NEURO III-SV | Imris, Inc. | 2008-12-16 | Traditional | PDF ↗ |
| K082427 | SYNGO MR B17 | Siemens Medical Solutions USA, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K083147 | DISCOVERY MR450 | Ge Medical Systems, LLC | 2008-11-04 | Traditional | PDF ↗ |
| K082331 | MAGNETOM C! | Siemens Medical Solutions USA, Inc. | 2008-10-01 | Traditional | PDF ↗ |
| K073425 | MODIFICATION TO AURORA MRI SYSTEM | Aurora Imaging Technology, Inc. | 2008-09-16 | Traditional | PDF ↗ |
| K082485 | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A | Neusoft Medical Systems Co., Ltd. | 2008-09-09 | Traditional | PDF ↗ |
| K082100 | ALLTECH ECHOSTAR 1.5 T MR SYSTEM | Alltech Medical Systems America, Inc. | 2008-08-06 | Traditional | PDF ↗ |
| K081916 | GE SIGNA MR ONCOLOGY PACKAGE | Ge Medical Systems, LLC | 2008-07-22 | Traditional | PDF ↗ |
| K073362 | MROPEN | Paramed S.R.L. | 2008-05-23 | Traditional | PDF ↗ |
| K080515 | FMRI HARDWARE SYSTEM | Nordicneurolab | 2008-05-16 | Traditional | PDF ↗ |
| K080762 | IB NEURO, VERSION 1.0 | Imaging Biometrics, LLC | 2008-05-15 | Traditional | PDF ↗ |
| K080968 | S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA | Esaote, S.p.A. | 2008-04-29 | Special | PDF ↗ |
| K081028 | SIGNA 3.0T MR750 SYSTEM | Ge Medical Systems, LLC | 2008-04-25 | Traditional | PDF ↗ |
| K080098 | MRJ EXTENDED | Paramed S.R.L. | 2008-03-10 | Traditional | PDF ↗ |
| K073156 | QPLAQUE MR | Medis Medical Imaging Systems BV | 2008-03-04 | Traditional | PDF ↗ |
| K080048 | MSK EXTREME MR SCANNER, MODEL AA5000 | Oni Medical Systems, Inc. | 2008-02-06 | Special | PDF ↗ |
| K073457 | MSTAR MPD4500 | Xinaomdt Technology Co., Ltd. | 2008-02-01 | Traditional | PDF ↗ |
| K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008-01-22 | Traditional | PDF ↗ |
| K073167 | BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER | Ge Medical Systems, LLC | 2008-01-04 | Traditional | PDF ↗ |
| K072473 | CHASE MR SYSTEM | Chase Medical, LP | 2007-12-10 | Traditional | PDF ↗ |
| K073081 | JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X | Toshiba America Medical Systems, In.C | 2007-11-21 | Traditional | PDF ↗ |
| K072850 | MRI SYSTEM, MODEL MAGFINDER II / AI 3200 | Advanced Imaging Laboratory | 2007-11-21 | Traditional | PDF ↗ |
| K073099 | FMRI HARDWARE SYSTEM | Nordicneurolab | 2007-11-20 | Traditional | PDF ↗ |
| K070968 | CHOY COMPRESSION FRAME | Choy Medical Technologies, Inc. | 2007-11-15 | Traditional | PDF ↗ |
| K072998 | IDEAL SOFTWARE OPTION FOR GE MR SCANNERS | Ge Medical Systems, LLC | 2007-11-01 | Traditional | PDF ↗ |
| K072237 | MAGNETOM VERIO | Siemens Medical Solutions USA, Inc. | 2007-10-10 | Traditional | PDF ↗ |
| K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | 2007-09-21 | Traditional | PDF ↗ |
| K071925 | MAGNETOM ESSENZA | Siemens Medical Solutions USA, Inc. | 2007-08-14 | Traditional | PDF ↗ |
| K071099 | NEURO II-SE, MODELS: OR-DR-OR, OR-MB | Imris, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K071154 | SUPERSTAR 0.35T MRI SYSTEM | Neusoft Medical Systems Co., Ltd. | 2007-05-10 | Traditional | PDF ↗ |
| K063559 | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 | Philips Medical Systems | 2007-01-04 | Traditional | PDF ↗ |
| K063361 | EXCELART VANTAGE ATLAS, MODEL MRT-1503 | Toshiba America Medical Systems, In.C | 2006-11-21 | Traditional | PDF ↗ |
| K063207 | S-SCAN MRI SYSTEM | Esaote, S.p.A. | 2006-11-09 | Special | PDF ↗ |
| K062454 | MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES | Siemens Medi Cal Solutions, Inc. | 2006-11-03 | Traditional | PDF ↗ |
| K062860 | MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A | Neusoft Medical Systems Co., Ltd. | 2006-10-27 | Special | PDF ↗ |
| K061916 | NEURO II-SE, MODELS OR-MB-DR AND OR-DR | Imris, Inc. | 2006-08-11 | Traditional | PDF ↗ |
| K061368 | DIAGNOSOFT HARP | Diagnosoft, Inc. | 2006-07-28 | Traditional | PDF ↗ |
| K061930 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY | Fonar Corp. | 2006-07-28 | Special | PDF ↗ |
| K061429 | DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA | Esaote, S.p.A. | 2006-07-25 | Traditional | PDF ↗ |
| K061255 | BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 | Kyron Clinical Imaging, Inc. | 2006-06-13 | Traditional | PDF ↗ |
| K061132 | MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 | Neusoft Medical Systems Co., Ltd. | 2006-05-24 | Special | PDF ↗ |
| K060956 | G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 | Esaote, S.p.A. | 2006-05-04 | Special | PDF ↗ |
| K053309 | ALTAIRE INTERVENTIONAL MR PACKAGE | Hitachi Medical Systems America, Inc. | 2006-01-24 | Abbreviated | PDF ↗ |
| K060003 | EXCELART VANTAGE ZGV | Toshibamedical Systems Corporation | 2006-01-18 | Traditional | PDF ↗ |
| K052423 | MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION | Siemens Medi Cal Solutions, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K052023 | CADIMAS VERSION 1.0 | Alan Penn & Associates., Inc. | 2005-12-08 | Traditional | PDF ↗ |
| K053009 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM | GE Medical Systems | 2005-11-17 | Special | PDF ↗ |
| K052978 | GE 1.5T SIGNA HDE MR SYSTEM | Ge Medical Systems, LLC | 2005-11-09 | Special | PDF ↗ |
| K052698 | MODIFICATION TO: AURORA | Aurora Imaging Technology, Inc. | 2005-11-08 | Special | PDF ↗ |
| K052987 | BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC | Noras Rontgen-Und Medizintechnik GmbH | 2005-11-08 | Special | PDF ↗ |
| K052571 | MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 | Neurognostics, Inc. | 2005-10-17 | Special | PDF ↗ |
| K052164 | MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A | Siemens Medical Solutions USA, Inc. | 2005-10-04 | Traditional | PDF ↗ |
| K052172 | HHF1 MAGNETIC RESONANCE IMAGING SYSTEM | Hitachi Medical Systems America, Inc. | 2005-09-27 | Abbreviated | PDF ↗ |
| K052579 | PORTAL GRAVITY SYSTEM | Portal, Inc. | 2005-09-27 | Traditional | PDF ↗ |
| K052315 | SIMTEC IM-MAXX 2 OPTION | Siemens Medical Solutions USA, Inc. | 2005-09-22 | Special | PDF ↗ |
| K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM | Ge Medical Systems, LLC | 2005-09-21 | Special | PDF ↗ |
| K052305 | MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A | Siemens Medical Solutions USA, Inc. | 2005-09-08 | Traditional | PDF ↗ |
| K052078 | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES | Philips Medical Systems Nederland B.V. | 2005-09-07 | Traditional | PDF ↗ |
| K052013 | ACHIEVA 1.5T & INERA 1.5T FAMILY | Philips Medical Systems Nederland B.V. | 2005-08-02 | Traditional | PDF ↗ |
| K050602 | ALTAIRE | Hitachi Medical Systems America, Inc. | 2005-04-07 | Special | PDF ↗ |
| K050237 | STARSHIELD V3 RF TRNT | Odin Medical Technologies , Ltd. | 2005-03-18 | Special | PDF ↗ |
| K050200 | MAGNETOM TRIO A TIM SYSTEM | Siemens Medical Solutions USA, Inc. | 2005-02-28 | Traditional | PDF ↗ |
| K050199 | MAGNETOM SYMPHONY A TIM SYSTEM | Siemens Medical Solution | 2005-02-18 | Traditional | PDF ↗ |
| K043147 | ACHIEVA FAMILY | Philips Medical Systems North America Co. | 2005-02-15 | Traditional | PDF ↗ |
| K050132 | NEURO II-S | Innovative Magnetic Resonance Imaging Systems, Inc. | 2005-02-15 | Traditional | PDF ↗ |
| K043290 | MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0 | Neurognostics, Inc. | 2005-01-28 | Traditional | PDF ↗ |
| K043271 | R2-MRI ANALYSIS SYSTEM | Inner Vision Biometrics Pty, Ltd. | 2005-01-21 | Traditional | PDF ↗ |
| K043262 | GE SIGNA EXCITE MR SURGICAL OPTION | GE Healthcare | 2005-01-12 | Traditional | PDF ↗ |
| K043030 | MAGNETOM C! MR SYSTEM | Siemens Medical Solutions | 2004-12-09 | Traditional | PDF ↗ |
| K043112 | GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM | General Electric Co. | 2004-11-24 | Special | PDF ↗ |
| K042948 | I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM | Wandong Medical | 2004-11-03 | Traditional | PDF ↗ |
| K042236 | G-SCAN | Esaote, S.p.A. | 2004-10-04 | Traditional | PDF ↗ |
| K041602 | PANORAMA 1.0T | Philips Medical Systems North America, Inc. | 2004-07-26 | Traditional | PDF ↗ |
| K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE | Usa Instruments, Inc. | 2004-07-23 | Special | PDF ↗ |
| K041286 | DYNACAD V1.0 | Mri Devices Corp. | 2004-07-21 | Traditional | PDF ↗ |
| K041112 | MAGNETOM ESPREE SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-07-21 | Traditional | PDF ↗ |
| K041111 | MAGNETOM C! MR SYSTEM | Siemens Medical Solutions USA, Inc. | 2004-07-16 | Traditional | PDF ↗ |
| K041020 | CADSTREAM VERSION 3.1 | Confirma, Inc. | 2004-07-07 | Traditional | PDF ↗ |
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | 2004-06-25 | Traditional | PDF ↗ |
| K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM | Ge Medical Systems, LLC | 2004-06-17 | Special | PDF ↗ |
| K040877 | ARTOSCAN C | Esaote, S.p.A. | 2004-05-04 | Special | PDF ↗ |
| K033485 | ENDOSCOUT | Robin Medical, Inc. | 2004-04-20 | Traditional | PDF ↗ |
| K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM | General Electric Co. | 2004-04-14 | Special | PDF ↗ |
| K033507 | MRJ | Paramed S.R.L. | 2004-01-20 | Traditional | PDF ↗ |
| K033867 | GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS | General Electric Co. | 2003-12-19 | Special | PDF ↗ |
| K033504 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM | General Electric Co. | 2003-11-25 | Special | PDF ↗ |
| K033315 | SUPEROPEN 0.23T, MODEL NAM-P023A | Neusoft Digital Medical Systems Co., Ltd. | 2003-10-29 | Traditional | PDF ↗ |
| K032428 | MAGNETOM AVANTO MR SYSTEM | Siemens Medical Solutions USA, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K033168 | GE 0.2T SIGNA PROFILE/I MR SYSTEM | General Electric Co. | 2003-10-10 | Special | PDF ↗ |
| K032795 | GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM | Ge Medical Systems, LLC | 2003-10-08 | Special | PDF ↗ |
| K032232 | AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE | Hitachi Medical Systems America, Inc. | 2003-09-29 | Abbreviated | PDF ↗ |
| K032678 | MODIFICATION TO: AURORA | Aurora Imaging Technology, Inc. | 2003-09-24 | Special | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.