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 6 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K032541 | POLESTAR N-20 | Odin Medical Technologies , Ltd. | 2003-09-12 | Special | PDF ↗ |
| K031815 | INTERA-SENSATION FAMILY | Philips Medical Systems | 2003-09-10 | Traditional | PDF ↗ |
| K032490 | TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 | Toshiba America Medical Systems, In.C | 2003-08-21 | Traditional | PDF ↗ |
| K032121 | MODIFICATION TO E-SCAN XQ | Esaote, S.p.A. | 2003-08-13 | Special | PDF ↗ |
| K031731 | MR FIBER OPTIC ECG GATING SYSTEM | Sa Instruments, Inc. | 2003-07-30 | Traditional | PDF ↗ |
| K032082 | AURORA | Aurora Imaging Technology, Inc. | 2003-07-30 | Special | PDF ↗ |
| K031927 | GE DELTA SOFTWARE OPTION FOR MRI | GE Medical Systems | 2003-07-02 | Traditional | PDF ↗ |
| K030981 | ECLIPSE | Varian Medical Systems, Inc. | 2003-06-24 | Traditional | PDF ↗ |
| K031350 | 3TP SOFTWARE OPTION | 3tp, LLC | 2003-06-23 | Traditional | PDF ↗ |
| K031396 | ADVANTAGE WORKSTATION PASTING 1.1 | GE Medical Systems | 2003-05-13 | Traditional | PDF ↗ |
| K031230 | GE PROPELLER IMAGING OPTION FOR MRI | GE Medical Systems | 2003-05-02 | Traditional | PDF ↗ |
| K030918 | SUPEROPEN 0.35T, MODEL NSM-P035 | Neusoft Digital Medical Systems Co., Ltd. | 2003-04-01 | Traditional | PDF ↗ |
| K030874 | GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM | General Electric Co. | 2003-03-28 | Special | PDF ↗ |
| K030520 | INTERA FAMILY | Philips Medical Systems North America Co. | 2003-03-06 | Traditional | PDF ↗ |
| K024042 | PANORAMA ENHANCEMENTS | Philips Medical Systems, Inc. | 2003-02-04 | Traditional | PDF ↗ |
| K024066 | INFINION SOFTWARE FEATURES | Philips Medical Systems (Cleveland), Inc. | 2003-02-04 | Traditional | PDF ↗ |
| K023686 | AURORA MR-GUIDED INTERVENTIONAL SYSTEM | Aurora Imaging Technology, Inc. | 2003-01-29 | Traditional | PDF ↗ |
| K023511 | EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002-11-05 | Traditional | PDF ↗ |
| K022390 | HITACHI ALTAIRE | Hitachi Medical Systems America, Inc. | 2002-10-11 | Abbreviated | PDF ↗ |
| K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM | Mri Devices Corp. | 2002-10-11 | Special | PDF ↗ |
| K023207 | OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) | Toshiba America Medical Systems, In.C | 2002-10-09 | Traditional | PDF ↗ |
| K022157 | RF TENT | Odin Medical Technologies , Ltd. | 2002-08-28 | Traditional | PDF ↗ |
| K022397 | SIGNA 3.0T MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2002-08-22 | Special | PDF ↗ |
| K020991 | SYNGO MR 2002B | Siemens Medical Solutions USA, Inc. | 2002-06-13 | Traditional | PDF ↗ |
| K020268 | ISAAC 1.5 T MR SYSTEM | Chi, Inc. | 2002-04-25 | Traditional | PDF ↗ |
| K020289 | MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS | Machnet BV | 2002-04-24 | Traditional | PDF ↗ |
| K020573 | MODIFICATION TO MAGNETOM RHAPSODY SYSTEM | Siemens Medical Solutions USA, Inc. | 2002-03-13 | Traditional | PDF ↗ |
| K020164 | E-SCAN XQ | Biosound Esaote, Inc. | 2002-02-12 | Special | PDF ↗ |
| K014011 | CANVAS N-VAS-D 2.0 | Vassol, Inc. | 2002-02-05 | Traditional | PDF ↗ |
| K013636 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY | GE Medical Systems | 2002-01-24 | Traditional | PDF ↗ |
| K013858 | INFINION 0.6T MR IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K013586 | MAGNETOM TRIO SYSTEM | Siemens Medical Systems, Inc. | 2001-12-28 | Traditional | PDF ↗ |
| K010850 | POLESTAR N-10 | Odin Medical Technologies , Ltd. | 2001-12-17 | Traditional | PDF ↗ |
| K013344 | INTERA I/T | Philips Medical Systems North America Co. | 2001-12-11 | Traditional | PDF ↗ |
| K012875 | SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-11-20 | Traditional | PDF ↗ |
| K012495 | OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS | Siemens Medical Solutions USA, Inc. | 2001-10-31 | Traditional | PDF ↗ |
| K013150 | MR-GUIDE 2000 | Ultraguide , Ltd. | 2001-10-18 | Special | PDF ↗ |
| K012202 | NUMARIS 4VA15A | Siemens Medical Corp. | 2001-09-27 | Traditional | PDF ↗ |
| K012970 | GE SIGNA ASSET IMAGING OPTION | GE Medical Systems | 2001-09-24 | Special | PDF ↗ |
| K012154 | AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Aurora Imaging Technology, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K011416 | MUSCLE IMAGING SYSTEM (MIS) | Millennium Magnetic Imaging, Inc. | 2001-08-06 | Traditional | PDF ↗ |
| K012200 | 1.5T INFINITY TWINSPEED MR SYSTEM | GE Medical Systems | 2001-08-03 | Special | PDF ↗ |
| K011296 | INFINION ENHANCEMENT PACKAGE | Philips Medical Systems (Cleveland), Inc. | 2001-07-19 | Traditional | PDF ↗ |
| K011485 | PINNACLE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 2001-06-06 | Special | PDF ↗ |
| K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | Sun Nuclear Corp. | 2001-06-06 | Special | PDF ↗ |
| K010773 | BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS | Siemens Medical Solutions USA, Inc. | 2001-05-30 | Traditional | PDF ↗ |
| K011418 | ULTRAGUIDE MR-GUIDE 3000 | Ultraguide , Ltd. | 2001-05-24 | Traditional | PDF ↗ |
| K010691 | BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION | Philips Medical Systems (Cleveland), Inc. | 2001-05-08 | Traditional | PDF ↗ |
| K002997 | FIESTA IMAGING OPTION | GE Medical Systems | 2001-04-11 | Traditional | PDF ↗ |
| K010570 | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 | Mri Devices Corp. | 2001-04-09 | Traditional | PDF ↗ |
| K003899 | IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM | Mri Devices Corp. | 2001-03-15 | Traditional | PDF ↗ |
| K003947 | FUNCTIONAL BRAIN MAPPING OPTION FOR MRI | GE Medical Systems | 2001-03-13 | Traditional | PDF ↗ |
| K003651 | AURORA | Aurora Imaging Technology, Inc. | 2001-02-21 | Traditional | PDF ↗ |
| K003853 | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 | Philips Medical Systems (Cleveland), Inc. | 2001-02-13 | Traditional | PDF ↗ |
| K010057 | MODIFICATION TO ARTOSCAN M | Biosound Esaote, Inc. | 2001-02-02 | Special | PDF ↗ |
| K003573 | DIFFUSION TENSOR IMAGING OPTION | Ge Medical Systems, Inc. | 2001-01-23 | Traditional | PDF ↗ |
| K003628 | MAGNETOM RHAPSODY SYSTEM | Siemens Medical Solutions USA, Inc. | 2001-01-23 | Abbreviated | PDF ↗ |
| K003453 | SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS | Fonar Corp. | 2001-01-18 | Traditional | PDF ↗ |
| K003516 | GYROSCAN INTERA 3.0T | Philips Medical Systems North America, Inc. | 2000-12-27 | Traditional | PDF ↗ |
| K003192 | MAGNETIC CONCERTO | Siemens Medical Solutions USA, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K003623 | INTERACTIVE REAL TIME SCANNING PACKAGE | Siemens Medical Solutions USA, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K002964 | NEURO II | Innovative Magnetic Resonance Imaging Systems, Inc. | 2000-12-19 | Traditional | PDF ↗ |
| K002611 | SIGNA MFO/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2000-10-31 | Traditional | PDF ↗ |
| K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 | Toshiba America Mri, Inc. | 2000-10-26 | Traditional | PDF ↗ |
| K002420 | HITACHI ALTAIRE | Hitachi Medical Systems America, Inc. | 2000-10-17 | Abbreviated | PDF ↗ |
| K002179 | MAGNETOM ALLEGRA SYSTEM | Siemens Medical Solutions USA, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K002490 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 2000-10-03 | Traditional | PDF ↗ |
| K002242 | POLESTAR N-10 | Odin Technologies , Ltd. | 2000-09-20 | Traditional | PDF ↗ |
| K001987 | EXPLORER GRADIENT | Philips Medical Systems North America, Inc. | 2000-09-06 | Traditional | PDF ↗ |
| K001796 | GYROSCAN INTERA (R7.5) | Philips Medical Systems North America, Inc. | 2000-09-06 | Traditional | PDF ↗ |
| K994283 | MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM | Medis Medical Imaging Systems BV | 2000-08-30 | Traditional | PDF ↗ |
| K002415 | POWERDRIVE 350 OPTION | Philips Medical Systems (Cleveland), Inc. | 2000-08-18 | Special | PDF ↗ |
| K001773 | ORTHONE | Oni, Inc. | 2000-08-18 | Abbreviated | PDF ↗ |
| K002225 | OR TABLE/MAGNETOM OPEN VIVA SYSTEM | Siemens Medical Solutions USA, Inc. | 2000-08-08 | Traditional | PDF ↗ |
| K001334 | HITACHI AIRIS II | Hitachi Medical Systems America, Inc. | 2000-07-06 | Traditional | PDF ↗ |
| K001894 | MODIFICATION TO E-SCAN | Biosound Esaote, Inc. | 2000-07-06 | Special | PDF ↗ |
| K000802 | SPIRAL IMAGING OPTION | GE Medical Systems | 2000-05-26 | Traditional | PDF ↗ |
| K000832 | STEROTACTIC LOCALIZATION DEVICE (SLD) | Philips Medical Systems North America, Inc. | 2000-04-27 | Traditional | PDF ↗ |
| K000315 | VENTRICULAR ANALYSIS TOOLKIT OPTION | GE Medical Systems | 2000-03-27 | Traditional | PDF ↗ |
| K994351 | M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM | Resonance Technology, Inc. | 2000-03-22 | Traditional | PDF ↗ |
| K994287 | FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 2000-03-16 | Traditional | PDF ↗ |
| K994282 | MRI- FLOW ANALYTICAL SOFTWARE PACKAGE | Medis Medical Imaging Systems BV | 2000-03-02 | Traditional | PDF ↗ |
| K993803 | EXCELART WITH PIANISSIMO | Toshiba America Mri, Inc. | 2000-02-06 | Traditional | PDF ↗ |
| K994117 | MR ENHANCER | I.Z.I. Corp. | 2000-02-04 | Traditional | PDF ↗ |
| K993682 | MRI EQUIPMENT COVER | Image-Guided Neurologics, Inc. | 2000-01-20 | Traditional | PDF ↗ |
| K993574 | OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON | Toshiba America Mri, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K994316 | MAGNETOM OPEN VIVA WITH PERMANENT MAGNET | Siemens Medical Corp. | 2000-01-14 | Special | PDF ↗ |
| K993731 | SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM | Siemens Medical Solutions USA, Inc. | 1999-12-23 | Traditional | PDF ↗ |
| K990329 | PHILIPS EASYVISION WORKSTATION | Philips Medical Systems North America, Inc. | 1999-12-07 | Traditional | PDF ↗ |
| K992746 | SIGNA HFO/I MAGNETIC RESONANCE SYSTEM | Ge Medical Systems, Inc. | 1999-11-09 | Traditional | PDF ↗ |
| K990826 | INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM | Siemens Medical Solutions USA, Inc. | 1999-11-01 | Traditional | PDF ↗ |
| K992533 | PHILIPS GYROSCAN INTERA (*) | Philips Medical Systems North America, Inc. | 1999-10-18 | Traditional | PDF ↗ |
| K990153 | VIRGO MRI SYSTEM | Millennium Technology Services | 1999-10-08 | Traditional | PDF ↗ |
| K983793 | PREFERENCE TREATMENT SYSTEM | Northwest Medical Physics Equipment, Inc. | 1999-10-05 | Traditional | PDF ↗ |
| K992892 | STEPPING KINEMATIC IMAGING PLATFORM (SKIP) | Magnetic Moments, LLC | 1999-09-16 | Traditional | PDF ↗ |
| K990335 | PHILIPS EASYVISION WORKSTATION: | Philips Medical Systems North America, Inc. | 1999-09-09 | Traditional | PDF ↗ |
| K992135 | SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM | Ge Medical Systems, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K992225 | QUANTITATIVE FLOW | Philips Medical Systems (Cleveland), Inc. | 1999-09-07 | Traditional | PDF ↗ |
| K991943 | MRGP OPTICAL TRACKING UNIT | Philips Medical Systems (Cleveland), Inc. | 1999-08-23 | Traditional | PDF ↗ |
| K992412 | IPASS BOLUS TRACKING | Philips Medical Systems (Cleveland), Inc. | 1999-08-17 | Special | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.