System, Nuclear Magnetic Resonance Imaging
Regulation 892.1000
28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
Top companies in LNH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2006 | K061132 | MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 Neusoft Medical Systems Co., Ltd., CN | LNH |
| May 4, 2006 | K060956 | G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 Esaote, S.p.A. | LNH |
| Jan 24, 2006 | K053309 | ALTAIRE INTERVENTIONAL MR PACKAGE Hitachi Medical Systems America, Inc. | LNH |
| Jan 18, 2006 | K060003 | EXCELART VANTAGE ZGV Toshibamedical Systems Corporation | LNH |
| Jan 13, 2006 | K052423 | MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION Siemens Medi Cal Solutions, Inc. | LNH |
| Dec 8, 2005 | K052023 | CADIMAS VERSION 1.0 Alan Penn & Associates., Inc. | LNH |
| Nov 17, 2005 | K053009 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE Medical Systems | LNH |
| Nov 9, 2005 | K052978 | GE 1.5T SIGNA HDE MR SYSTEM Ge Medical Systems, LLC | LNH |
| Nov 8, 2005 | K052987 | BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC Noras Rontgen-Und Medizintechnik GmbH | LNH |
| Nov 8, 2005 | K052698 | MODIFICATION TO: AURORA Aurora Imaging Technology, Inc. | LNH |
| Oct 17, 2005 | K052571 | MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 Neurognostics, Inc. | LNH |
| Oct 4, 2005 | K052164 | MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A Siemens Medical Solutions USA, Inc. | LNH |
| Sep 27, 2005 | K052579 | PORTAL GRAVITY SYSTEM Portal, Inc. | LNH |
| Sep 27, 2005 | K052172 | HHF1 MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc. | LNH |
| Sep 22, 2005 | K052315 | SIMTEC IM-MAXX 2 OPTION Siemens Medical Solutions USA, Inc. | LNH |
| Sep 21, 2005 | K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM Ge Medical Systems, LLC | LNH |
| Sep 8, 2005 | K052305 | MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A Siemens Medical Solutions USA, Inc. | LNH |
| Sep 7, 2005 | K052078 | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES Philips Medical Systems Nederland B.V. | LNH |
| Aug 2, 2005 | K052013 | ACHIEVA 1.5T & INERA 1.5T FAMILY Philips Medical Systems Nederland B.V. | LNH |
| Apr 7, 2005 | K050602 | ALTAIRE Hitachi Medical Systems America, Inc. | LNH |
| Mar 18, 2005 | K050237 | STARSHIELD V3 RF TRNT Odin Medical Technologies , Ltd., IL | LNH |
| Feb 28, 2005 | K050200 | MAGNETOM TRIO A TIM SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Feb 18, 2005 | K050199 | MAGNETOM SYMPHONY A TIM SYSTEM Siemens Medical Solution | LNH |
| Feb 15, 2005 | K050132 | NEURO II-S Innovative Magnetic Resonance Imaging Systems, Inc. | LNH |
| Feb 15, 2005 | K043147 | ACHIEVA FAMILY Philips Medical Systems North America Co. | LNH |
| Jan 28, 2005 | K043290 | MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0 Neurognostics, Inc. | LNH |
| Jan 21, 2005 | K043271 | R2-MRI ANALYSIS SYSTEM Inner Vision Biometrics Pty, Ltd., AU | LNH |
| Jan 12, 2005 | K043262 | GE SIGNA EXCITE MR SURGICAL OPTION GE Healthcare | LNH |
| Dec 9, 2004 | K043030 | MAGNETOM C! MR SYSTEM Siemens Medical Solutions | LNH |
| Nov 24, 2004 | K043112 | GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM General Electric Co. | LNH |
| Nov 3, 2004 | K042948 | I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM Wandong Medical, CN | LNH |
| Oct 4, 2004 | K042236 | G-SCAN Esaote, S.p.A. | LNH |
| Jul 26, 2004 | K041602 | PANORAMA 1.0T Philips Medical Systems North America, Inc. | LNH |
| Jul 23, 2004 | K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE Usa Instruments, Inc. | LNH |
| Jul 21, 2004 | K041286 | DYNACAD V1.0 Mri Devices Corp. | LNH |
| Jul 21, 2004 | K041112 | MAGNETOM ESPREE SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Jul 16, 2004 | K041111 | MAGNETOM C! MR SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Jul 7, 2004 | K041020 | CADSTREAM VERSION 3.1 Confirma, Inc. | LNH |
| Jun 25, 2004 | K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories | LNH |
| Jun 17, 2004 | K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM Ge Medical Systems, LLC | LNH |
| May 4, 2004 | K040877 | ARTOSCAN C Esaote, S.p.A. | LNH |
| Apr 20, 2004 | K033485 | ENDOSCOUT Robin Medical, Inc., IL | LNH |
| Apr 14, 2004 | K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM General Electric Co. | LNH |
| Jan 20, 2004 | K033507 | MRJ Paramed S.R.L. | LNH |
| Dec 19, 2003 | K033867 | GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS General Electric Co. | LNH |
| Nov 25, 2003 | K033504 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM General Electric Co. | LNH |
| Oct 29, 2003 | K033315 | SUPEROPEN 0.23T, MODEL NAM-P023A Neusoft Digital Medical Systems Co., Ltd., CN | LNH |
| Oct 16, 2003 | K032428 | MAGNETOM AVANTO MR SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Oct 10, 2003 | K033168 | GE 0.2T SIGNA PROFILE/I MR SYSTEM General Electric Co. | LNH |
| Oct 8, 2003 | K032795 | GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM Ge Medical Systems, LLC | LNH |
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