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 7 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K992120 | DYNAWELL OR DYNAWELL | Ekeroth Quality AB | 1999-08-13 | Traditional | PDF ↗ |
| K991652 | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM | Siemens Corp. | 1999-08-03 | Traditional | PDF ↗ |
| K991243 | NORMA 10 | Odin Technologies , Ltd. | 1999-06-18 | Traditional | PDF ↗ |
| K990968 | E-SCAN | Biosound Esaote, Inc. | 1999-05-27 | Traditional | PDF ↗ |
| K990620 | EXCELART | Toshiba America Mri, Inc. | 1999-05-14 | Traditional | PDF ↗ |
| K990550 | 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | Ge Medical Systems, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K990260 | OPART | Toshiba America Mri, Inc. | 1999-04-15 | Traditional | PDF ↗ |
| K983110 | FLEXART,FLEXART/HYPER, VISART, VISART/HYPER | Toshiba America Mri, Inc. | 1999-02-25 | Traditional | PDF ↗ |
| K984221 | FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR | Siemens Corp. | 1999-02-12 | Traditional | PDF ↗ |
| K984280 | AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE | Hitachi Medical Systems America, Inc. | 1999-02-08 | Traditional | PDF ↗ |
| K984224 | PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS | Siemens Corp. | 1999-02-02 | Traditional | PDF ↗ |
| K984274 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE | Hitachi Medical Systems America, Inc. | 1999-01-25 | Traditional | PDF ↗ |
| K983902 | FIELD EFFECTS MRI SYSTEM | Intermagnetics General Corp. | 1999-01-07 | Traditional | PDF ↗ |
| K982959 | MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC | Medrad, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K982932 | MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC | Medrad, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K982834 | RESTGRID PACKAGE/GYROSCAN NT | Philips Medical Systems North America, Inc. | 1998-10-29 | Traditional | PDF ↗ |
| K982761 | JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 | Chamco, Inc. | 1998-10-22 | Traditional | PDF ↗ |
| K983327 | ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS | Siemens Medical Solutions USA, Inc. | 1998-10-09 | Traditional | PDF ↗ |
| K982157 | TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Field Effects | 1998-09-02 | Traditional | PDF ↗ |
| K980831 | IMAGE POST-PROCESSING TECHNIQUES | Philips Medical Systems (Cleveland), Inc. | 1998-08-27 | Traditional | PDF ↗ |
| K981898 | ORTHOVU-1000 | Magnevu | 1998-08-03 | Traditional | PDF ↗ |
| K981475 | OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE | Toshiba America Mri, Inc. | 1998-07-14 | Traditional | PDF ↗ |
| K981190 | HIGH IMPEDANCE CARDIAC GATING CABLE | GE Medical Systems | 1998-06-30 | Traditional | PDF ↗ |
| K981410 | HAMMERSMITH ENDOCAVITARY COILS | Philips Medical Systems (Cleveland), Inc. | 1998-06-30 | Traditional | PDF ↗ |
| K981398 | ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM | Interneuron Pharmaceuticals, Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K980645 | PHILIPS GYROSCAN NT RELEASE 6 SERIES | Philips Medical Systems North America, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K973658 | DIFFUSION PACKAGE / GYROSCAN NT | Philips Medical Systems North America, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980417 | MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V | Medrad, Inc. | 1998-05-04 | Traditional | PDF ↗ |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | Elscint, Inc. | 1998-04-02 | Traditional | PDF ↗ |
| K980114 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1998-03-30 | Traditional | PDF ↗ |
| K974844 | OUTLOOK SYSTEM ENHANCEMENT PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1998-03-10 | Traditional | PDF ↗ |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | Elscint, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K974498 | STRATIS II | Hitachi Medical Systems America, Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K974212 | AIRIS II | Hitachi Medical Systems America, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K974530 | DUFFUSION-WEIGHTED MR IMAGING PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1998-02-06 | Traditional | PDF ↗ |
| K972990 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1998-02-05 | Traditional | PDF ↗ |
| K973799 | CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT | Siemens Medical Solutions USA, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K972826 | ESTEEM 1.5T MRI SYSTEM | Elscint Mr, Inc. | 1997-10-15 | Traditional | PDF ↗ |
| K972704 | KINEMATIC POSITIONERS | Ge Medical Systems, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K970990 | GYREX PRIMA 1TG 1.0T MRI SYSTEM | Elscint Mr, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K971884 | ASSET APOLLO | Philips Medical Systems (Cleveland), Inc. | 1997-08-20 | Traditional | PDF ↗ |
| K971684 | MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) | Siemens Medical Solutions USA, Inc. | 1997-08-05 | Traditional | PDF ↗ |
| K971668 | SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS | GE Medical Systems | 1997-07-24 | Traditional | PDF ↗ |
| K970573 | FLEXART V3.5 SOFTWARE | Toshiba America Mri, Inc. | 1997-07-21 | Traditional | PDF ↗ |
| K965068 | MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE | Toshiba America Medical Systems, In.C | 1997-07-15 | Traditional | PDF ↗ |
| K971380 | MEDRAD FLEX INTERFACE DEVICE | Medrad, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K971279 | VERSION 4 OPERATING SYSTEM SOFTWARE | Hitachi Medical Systems America, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K971055 | DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION | Siemens Medical Solutions USA, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | Elscint, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K970852 | MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) | Siemens Medical Solutions USA, Inc. | 1997-06-05 | Traditional | PDF ↗ |
| K963990 | GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES | Philips Medical Systems, Inc. | 1997-05-29 | Traditional | PDF ↗ |
| K963262 | ARTOSCAN M | Biosound, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K970037 | TARGOGRID | Daum GmbH | 1997-03-12 | Traditional | PDF ↗ |
| K964752 | KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER | Philips Medical Systems (Cleveland), Inc. | 1997-02-24 | Traditional | PDF ↗ |
| K964778 | HI-STAR MRI IMAGING SYSTEM | Health Images, Inc. | 1997-02-24 | Traditional | PDF ↗ |
| K964753 | MATRIX 3000 FLEXIBLE SPINE COIL | Us Asia Instruments, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K964626 | EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K964608 | MRT-35A V9.0 | Toshiba America Mri, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K964531 | PROFILE 70000 QUADRATURE VOLUME NECK COIL | Us Asia Instruments, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K964306 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | General Electric Co. | 1997-01-17 | Traditional | PDF ↗ |
| K962249 | PIXELL MRI SYSTEM | General Medical Equipment Corp. | 1997-01-10 | Traditional | PDF ↗ |
| K964370 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1997-01-10 | Traditional | PDF ↗ |
| K962138 | FLEXART V3.1 SOFTWARE | Toshiba America Mri, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K963953 | IMIG-MRI | Imig-Mri Systems, LLC | 1996-12-18 | Traditional | PDF ↗ |
| K962061 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1996-11-27 | Traditional | PDF ↗ |
| K963429 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1996-11-27 | Traditional | PDF ↗ |
| K963186 | ORTHO 8000 | Inner Vision Mri , Ltd. | 1996-11-12 | Traditional | PDF ↗ |
| K963179 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1996-11-07 | Traditional | PDF ↗ |
| K962892 | HELAX TMS BRACHYTHERAPY, VERSION 3.0 | Siemens Medical Solutions USA, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K962933 | OPART MRT-600 | Toshiba America Mri, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K961624 | FLEXART TMJ COIL | Toshiba America Mri, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K963345 | ADVANTAGE WINDOWS TISSUE VOLUME OPTION | GE Medical Systems | 1996-10-18 | Traditional | PDF ↗ |
| K962927 | IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS | Siemens Medical Solutions USA, Inc. | 1996-09-25 | Traditional | PDF ↗ |
| K962677 | ESTEEM 1.5T MRI SYSTEM | Elscint Mr, Inc. | 1996-09-20 | Traditional | PDF ↗ |
| K961969 | HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE | Hitachi Medical Systems America, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K962618 | GYREX V-EP | Elscint, Inc. | 1996-09-04 | Traditional | PDF ↗ |
| K962117 | QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS | Philips Medical Systems (Cleveland), Inc. | 1996-08-27 | Traditional | PDF ↗ |
| K962048 | 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) | Hitachi Medical Systems America, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K961842 | SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM | Toshiba America Mri, Inc. | 1996-08-02 | Traditional | PDF ↗ |
| K961876 | AIRIS | Hitachi Medical Systems America, Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K960497 | FLEXIBLE PHASED ARRAY SPINE COIL | Philips Medical Systems (Cleveland), Inc. | 1996-07-05 | Traditional | PDF ↗ |
| K961366 | MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS | Mri Devices Corp. | 1996-07-03 | Traditional | PDF ↗ |
| K961238 | MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1 | Toshiba America Mri, Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K961174 | ECG MONITOR MODEL DS-3130/3140 | Hitachi Medical Systems America, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K961121 | KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM | Siemens Medical Solutions USA, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K961092 | VISART | Toshiba America Medical Systems, In.C | 1996-06-14 | Traditional | PDF ↗ |
| K955389 | MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM | Siemens Medical Solutions USA, Inc. | 1996-06-10 | Traditional | PDF ↗ |
| K960901 | MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL | Medrad, Inc. | 1996-05-29 | Traditional | PDF ↗ |
| K960973 | MOVABLE ADD-ON COUCH FOR OUTLOOK | Philips Medical Systems (Cleveland), Inc. | 1996-05-29 | Traditional | PDF ↗ |
| K960294 | PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK | Philips Medical Systems (Cleveland), Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K954354 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | General Electric Co. | 1996-04-12 | Traditional | PDF ↗ |
| K954353 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | General Electric Co. | 1996-04-12 | Traditional | PDF ↗ |
| K955811 | AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM | Siemens Medical Solutions USA, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K960181 | VERSION 3.7 OPERATING SYSTEM SOFTWARE | Hitachi Medical Systems America, Inc. | 1996-03-05 | Traditional | PDF ↗ |
| K950837 | AURORA IMAGING SYSTEM | Advanced Mammography Systems, Inc. | 1996-02-26 | Traditional | PDF ↗ |
| K954646 | EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS | Philips Medical Systems (Cleveland), Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K945945 | GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT | Philips Medical Systems North America, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K942604 | SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 1995-11-24 | Traditional | PDF ↗ |
| K954039 | GYREX PRIVILEGE | Elscint, Inc. | 1995-11-24 | Traditional | PDF ↗ |
| K951650 | CLINICAL PROTON SPECTROSCOPY OPTION | Siemens Medical Solutions USA, Inc. | 1995-11-14 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.