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 |
|---|---|---|---|
| Sep 29, 2003 | K032232 | AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE Hitachi Medical Systems America, Inc. | LNH |
| Sep 24, 2003 | K032678 | MODIFICATION TO: AURORA Aurora Imaging Technology, Inc. | LNH |
| Sep 12, 2003 | K032541 | POLESTAR N-20 Odin Medical Technologies , Ltd., IL | LNH |
| Sep 10, 2003 | K031815 | INTERA-SENSATION FAMILY Philips Medical Systems | LNH |
| Aug 21, 2003 | K032490 | TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 Toshiba America Medical Systems, In.C | LNH |
| Aug 13, 2003 | K032121 | MODIFICATION TO E-SCAN XQ Esaote, S.p.A. | LNH |
| Jul 30, 2003 | K032082 | AURORA Aurora Imaging Technology, Inc. | LNH |
| Jul 30, 2003 | K031731 | MR FIBER OPTIC ECG GATING SYSTEM Sa Instruments, Inc. | LNH |
| Jul 2, 2003 | K031927 | GE DELTA SOFTWARE OPTION FOR MRI GE Medical Systems | LNH |
| Jun 24, 2003 | K030981 | ECLIPSE Varian Medical Systems, Inc. | LNH |
| Jun 23, 2003 | K031350 | 3TP SOFTWARE OPTION 3tp, LLC | LNH |
| May 13, 2003 | K031396 | ADVANTAGE WORKSTATION PASTING 1.1 GE Medical Systems | LNH |
| May 2, 2003 | K031230 | GE PROPELLER IMAGING OPTION FOR MRI GE Medical Systems | LNH |
| Apr 1, 2003 | K030918 | SUPEROPEN 0.35T, MODEL NSM-P035 Neusoft Digital Medical Systems Co., Ltd., CN | LNH |
| Mar 28, 2003 | K030874 | GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM General Electric Co. | LNH |
| Mar 6, 2003 | K030520 | INTERA FAMILY Philips Medical Systems North America Co. | LNH |
| Feb 4, 2003 | K024066 | INFINION SOFTWARE FEATURES Philips Medical Systems (Cleveland), Inc. | LNH |
| Feb 4, 2003 | K024042 | PANORAMA ENHANCEMENTS Philips Medical Systems, Inc. | LNH |
| Jan 29, 2003 | K023686 | AURORA MR-GUIDED INTERVENTIONAL SYSTEM Aurora Imaging Technology, Inc. | LNH |
| Nov 5, 2002 | K023511 | EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 Toshiba America Medical Systems, In.C | LNH |
| Oct 11, 2002 | K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM Mri Devices Corp. | LNH |
| Oct 11, 2002 | K022390 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc. | LNH |
| Oct 9, 2002 | K023207 | OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) Toshiba America Medical Systems, In.C | LNH |
| Aug 28, 2002 | K022157 | RF TENT Odin Medical Technologies , Ltd., IL | LNH |
| Aug 22, 2002 | K022397 | SIGNA 3.0T MAGNETIC RESONANCE SYSTEM GE Medical Systems | LNH |
| Jun 13, 2002 | K020991 | SYNGO MR 2002B Siemens Medical Solutions USA, Inc. | LNH |
| Apr 25, 2002 | K020268 | ISAAC 1.5 T MR SYSTEM Chi, Inc. | LNH |
| Apr 24, 2002 | K020289 | MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS Machnet BV | LNH |
| Mar 13, 2002 | K020573 | MODIFICATION TO MAGNETOM RHAPSODY SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Feb 12, 2002 | K020164 | E-SCAN XQ Biosound Esaote, Inc. | LNH |
| Feb 5, 2002 | K014011 | CANVAS N-VAS-D 2.0 Vassol, Inc. | LNH |
| Jan 24, 2002 | K013636 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE Medical Systems | LNH |
| Jan 22, 2002 | K013858 | INFINION 0.6T MR IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. | LNH |
| Dec 28, 2001 | K013586 | MAGNETOM TRIO SYSTEM Siemens Medical Systems, Inc. | LNH |
| Dec 17, 2001 | K010850 | POLESTAR N-10 Odin Medical Technologies , Ltd., IL | LNH |
| Dec 11, 2001 | K013344 | INTERA I/T Philips Medical Systems North America Co. | LNH |
| Nov 20, 2001 | K012875 | SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM GE Medical Systems | LNH |
| Oct 31, 2001 | K012495 | OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS Siemens Medical Solutions USA, Inc. | LNH |
| Oct 18, 2001 | K013150 | MR-GUIDE 2000 Ultraguide , Ltd. | LNH |
| Sep 27, 2001 | K012202 | NUMARIS 4VA15A Siemens Medical Corp. | LNH |
| Sep 24, 2001 | K012970 | GE SIGNA ASSET IMAGING OPTION GE Medical Systems | LNH |
| Sep 19, 2001 | K012154 | AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE Aurora Imaging Technology, Inc. | LNH |
| Aug 6, 2001 | K011416 | MUSCLE IMAGING SYSTEM (MIS) Millennium Magnetic Imaging, Inc. | LNH |
| Aug 3, 2001 | K012200 | 1.5T INFINITY TWINSPEED MR SYSTEM GE Medical Systems | LNH |
| Jul 19, 2001 | K011296 | INFINION ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc. | LNH |
| Jun 6, 2001 | K011485 | PINNACLE MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. | LNH |
| Jun 6, 2001 | K011466 | QED DIODE DETECTORS, MODELS 1112-1116 Sun Nuclear Corp. | LNH |
| May 30, 2001 | K010773 | BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS Siemens Medical Solutions USA, Inc. | LNH |
| May 24, 2001 | K011418 | ULTRAGUIDE MR-GUIDE 3000 Ultraguide , Ltd. | LNH |
| May 8, 2001 | K010691 | BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION Philips Medical Systems (Cleveland), Inc. | LNH |
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