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 |
|---|---|---|---|
| Apr 11, 2001 | K002997 | FIESTA IMAGING OPTION GE Medical Systems | LNH |
| Apr 9, 2001 | K010570 | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 Mri Devices Corp. | LNH |
| Mar 15, 2001 | K003899 | IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM Mri Devices Corp. | LNH |
| Mar 13, 2001 | K003947 | FUNCTIONAL BRAIN MAPPING OPTION FOR MRI GE Medical Systems | LNH |
| Feb 21, 2001 | K003651 | AURORA Aurora Imaging Technology, Inc. | LNH |
| Feb 13, 2001 | K003853 | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 Philips Medical Systems (Cleveland), Inc. | LNH |
| Feb 2, 2001 | K010057 | MODIFICATION TO ARTOSCAN M Biosound Esaote, Inc. | LNH |
| Jan 23, 2001 | K003628 | MAGNETOM RHAPSODY SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Jan 23, 2001 | K003573 | DIFFUSION TENSOR IMAGING OPTION Ge Medical Systems, Inc. | LNH |
| Jan 18, 2001 | K003453 | SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS Fonar Corp. | LNH |
| Dec 27, 2000 | K003516 | GYROSCAN INTERA 3.0T Philips Medical Systems North America, Inc. | LNH |
| Dec 21, 2000 | K003623 | INTERACTIVE REAL TIME SCANNING PACKAGE Siemens Medical Solutions USA, Inc. | LNH |
| Dec 21, 2000 | K003192 | MAGNETIC CONCERTO Siemens Medical Solutions USA, Inc. | LNH |
| Dec 19, 2000 | K002964 | NEURO II Innovative Magnetic Resonance Imaging Systems, Inc. | LNH |
| Oct 31, 2000 | K002611 | SIGNA MFO/I MAGNETIC RESONANCE SYSTEM GE Medical Systems | LNH |
| Oct 26, 2000 | K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 Toshiba America Mri, Inc. | LNH |
| Oct 17, 2000 | K002420 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc. | LNH |
| Oct 11, 2000 | K002179 | MAGNETOM ALLEGRA SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Oct 3, 2000 | K002490 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. | LNH |
| Sep 20, 2000 | K002242 | POLESTAR N-10 Odin Technologies , Ltd., IL | LNH |
| Sep 6, 2000 | K001987 | EXPLORER GRADIENT Philips Medical Systems North America, Inc. | LNH |
| Sep 6, 2000 | K001796 | GYROSCAN INTERA (R7.5) Philips Medical Systems North America, Inc. | LNH |
| Aug 30, 2000 | K994283 | MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM Medis Medical Imaging Systems BV, NL | LNH |
| Aug 18, 2000 | K002415 | POWERDRIVE 350 OPTION Philips Medical Systems (Cleveland), Inc. | LNH |
| Aug 18, 2000 | K001773 | ORTHONE Oni, Inc. | LNH |
| Aug 8, 2000 | K002225 | OR TABLE/MAGNETOM OPEN VIVA SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Jul 6, 2000 | K001894 | MODIFICATION TO E-SCAN Biosound Esaote, Inc. | LNH |
| Jul 6, 2000 | K001334 | HITACHI AIRIS II Hitachi Medical Systems America, Inc. | LNH |
| May 26, 2000 | K000802 | SPIRAL IMAGING OPTION GE Medical Systems | LNH |
| Apr 27, 2000 | K000832 | STEROTACTIC LOCALIZATION DEVICE (SLD) Philips Medical Systems North America, Inc. | LNH |
| Mar 27, 2000 | K000315 | VENTRICULAR ANALYSIS TOOLKIT OPTION GE Medical Systems | LNH |
| Mar 22, 2000 | K994351 | M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM Resonance Technology, Inc. | LNH |
| Mar 16, 2000 | K994287 | FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. | LNH |
| Mar 2, 2000 | K994282 | MRI- FLOW ANALYTICAL SOFTWARE PACKAGE Medis Medical Imaging Systems BV, NL | LNH |
| Feb 6, 2000 | K993803 | EXCELART WITH PIANISSIMO Toshiba America Mri, Inc. | LNH |
| Feb 4, 2000 | K994117 | MR ENHANCER I.Z.I. Corp. | LNH |
| Jan 20, 2000 | K993682 | MRI EQUIPMENT COVER Image-Guided Neurologics, Inc. | LNH |
| Jan 18, 2000 | K993574 | OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON Toshiba America Mri, Inc. | LNH |
| Jan 14, 2000 | K994316 | MAGNETOM OPEN VIVA WITH PERMANENT MAGNET Siemens Medical Corp. | LNH |
| Dec 23, 1999 | K993731 | SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Dec 7, 1999 | K990329 | PHILIPS EASYVISION WORKSTATION Philips Medical Systems North America, Inc. | LNH |
| Nov 9, 1999 | K992746 | SIGNA HFO/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc. | LNH |
| Nov 1, 1999 | K990826 | INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM Siemens Medical Solutions USA, Inc. | LNH |
| Oct 18, 1999 | K992533 | PHILIPS GYROSCAN INTERA (*) Philips Medical Systems North America, Inc. | LNH |
| Oct 8, 1999 | K990153 | VIRGO MRI SYSTEM Millennium Technology Services | LNH |
| Oct 5, 1999 | K983793 | PREFERENCE TREATMENT SYSTEM Northwest Medical Physics Equipment, Inc. | LNH |
| Sep 16, 1999 | K992892 | STEPPING KINEMATIC IMAGING PLATFORM (SKIP) Magnetic Moments, LLC | LNH |
| Sep 9, 1999 | K990335 | PHILIPS EASYVISION WORKSTATION: Philips Medical Systems North America, Inc. | LNH |
| Sep 8, 1999 | K992135 | SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM Ge Medical Systems, Inc. | LNH |
| Sep 7, 1999 | K992225 | QUANTITATIVE FLOW Philips Medical Systems (Cleveland), Inc. | LNH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.