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 8 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K954355 | ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION | General Electric Co. | 1995-11-14 | Traditional | PDF ↗ |
| K951681 | QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 1995-11-09 | Traditional | PDF ↗ |
| K953248 | IRIS BILATERAL TMJ | Hitachi Medical Systems America, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K953262 | QD BILATERAL BREAST COIL | Hitachi Medical Systems America, Inc. | 1995-10-17 | Traditional | PDF ↗ |
| K945517 | MAGNETOM VISION (PROJECT 016) | Siemens Medical Solutions USA, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K943440 | PROFILE 7000 C-SPINE COIL | Us Asia Instruments, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K945791 | GYRES 2T PRESTIGE | Elscint, Inc. | 1995-09-19 | Traditional | PDF ↗ |
| K945827 | OUTLOOK | Philips Medical Systems (Cleveland), Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K953918 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K944724 | HEALTH IMAGE INC. HI STAR | Health Images, Inc. | 1995-08-30 | Traditional | PDF ↗ |
| K945779 | MAGNETOM VISION (PROJECT 016) | Siemens Medical Solutions USA, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K945730 | SIGNA PROFILE | GE Medical Systems | 1995-08-09 | Traditional | PDF ↗ |
| K943189 | MEDRAD QWIK-FIX MRI DISPOSABLE KIT | Medrad, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K952530 | HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1995-07-24 | Traditional | PDF ↗ |
| K944228 | HEALTH IMAGES, INC. HI-STANDARD | Health Images, Inc. | 1995-07-20 | Traditional | PDF ↗ |
| K952232 | MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 | Medrad, Inc. | 1995-06-26 | Traditional | PDF ↗ |
| K952235 | MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15 | Medrad, Inc. | 1995-06-26 | Traditional | PDF ↗ |
| K951649 | MODEL #801GE1500 PEDIATRIC ARRAY COIL | Medic, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K944070 | ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING | Advanced Nmr Systems, Inc. | 1995-06-19 | Traditional | PDF ↗ |
| K941666 | SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS | General Electric Co. | 1995-06-19 | Traditional | PDF ↗ |
| K944979 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | GE Medical Systems | 1995-06-13 | Traditional | PDF ↗ |
| K946085 | THIN-FILM CARDIAC GATING CABLE | General Electric Co. | 1995-06-05 | Traditional | PDF ↗ |
| K945155 | AIRIS | Hitachi Medical Systems America, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K943798 | MRH-1500 | Hitachi Medical Systems America, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K950973 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | GE Medical Systems | 1995-05-11 | Traditional | PDF ↗ |
| K945875 | MRT-50 QD BODY COIL | Toshiba America Mri, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K945828 | ECHO PLANAR IMAGING I | Philips Medical Systems (Cleveland), Inc. | 1995-04-12 | Traditional | PDF ↗ |
| K940772 | ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER) | Fonar Corp. | 1995-04-10 | Traditional | PDF ↗ |
| K945665 | FLEXART(TM) QD C-SPINE COIL | Toshiba America Mri, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K945798 | MRT-35A UPGRADE 8.0CD | Toshiba America Mri, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K945778 | PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL | Medical Advances, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K945386 | STRATIS | Hitachi Medical Systems America, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K945397 | ANGIO II | Philips Medical Systems (Cleveland), Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K946244 | ACCESS(TM) COMPASS BED | Toshiba America Mri, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K942669 | SMT-50CX/H | Shimadzu Medical Systems | 1995-02-02 | Traditional | PDF ↗ |
| K941864 | MRT-150A, MRT-150A SOFTWARE VERSION 11.9 | Toshiba America Mri, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K941622 | ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION | Siemens Medical Solutions USA, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K944662 | FLEXART QD BODY COIL | Toshiba America Mri, Inc. | 1995-01-25 | Traditional | PDF ↗ |
| K944773 | MODEL 405GE-64: PHASED ARRAY TMJ COIL | Medical Advances, Inc. | 1995-01-25 | Traditional | PDF ↗ |
| K944469 | GENERAL PURPOSE FLEX COIL | Philips Medical Systems (Cleveland), Inc. | 1995-01-25 | Traditional | PDF ↗ |
| K944331 | MODEL 528GE SERIES | Medical Advances, Inc. | 1995-01-25 | Traditional | PDF ↗ |
| K943800 | 2D,3D, TOF MR ANGIOGRAPHY | Hitachi Medical Systems America, Inc. | 1994-12-30 | Traditional | PDF ↗ |
| K941582 | SUPERSENSOR MRI COIL | Superconductor Technologies, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K944112 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | GE Medical Systems | 1994-12-22 | Traditional | PDF ↗ |
| K943415 | MERIT (O.1T MR SYSTEM) | Philips Medical Systems (Cleveland), Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K943799 | VERSION 5 OPERATING SYSTEM SOFTWARE | Hitachi Medical Systems America, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K942874 | MODEL #300TO3500 SHOULDER COIL | Medic, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K942873 | MODEL #700TO3500 NECK/ABDOMINAL COIL | Medic, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K942875 | MODEL #900TO3500 HEAD/NECK COIL | Medic, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K943320 | HEAD AND NECK COIL FOR THE GYREX 2T-DLX | Elscint, Inc. | 1994-11-29 | Traditional | PDF ↗ |
| K940534 | GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) | Philips Medical Systems, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K940541 | MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF) | Siemens Medical Solutions USA, Inc. | 1994-11-07 | Traditional | PDF ↗ |
| K943021 | MRT-150A | Toshiba America Mri, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K942953 | ORACLE MRI WHOLE BODY MR IMAGING SYSTEM | Otsuka Electronics USA, Inc. | 1994-09-30 | Traditional | PDF ↗ |
| K943321 | QUAD PELVIS COIL | Hitachi Medical Systems America, Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K942776 | MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1 | Otsuka Electronics USA, Inc. | 1994-09-21 | Traditional | PDF ↗ |
| K934987 | CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX | Elscint, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K942355 | MODEL #310T03500 WRIST COIL | Medic, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K942560 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | 1994-09-09 | Traditional | PDF ↗ |
| K940894 | MAGNA SL | Magna-Lab, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K942609 | MRT-150A SHOULDER COIL | Toshiba America Mri, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K941996 | EDGE | Philips Medical Systems (Cleveland), Inc. | 1994-08-25 | Traditional | PDF ↗ |
| K935549 | GYREX 2T-SGR | Elscint, Inc. | 1994-08-24 | Traditional | PDF ↗ |
| K940796 | ACCESS | Toshiba America Mri, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K934318 | DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL | Diagnostic Instrument Corp. | 1994-08-22 | Traditional | PDF ↗ |
| K941812 | SLICES | Microsignal Corp. | 1994-08-12 | Traditional | PDF ↗ |
| K935691 | MODEL GP-252 GENERAL PURPOSE COIL | Diagnostic Instrument Corp. | 1994-08-01 | Traditional | PDF ↗ |
| K941408 | MERIT | Philips Medical Systems (Cleveland), Inc. | 1994-07-28 | Traditional | PDF ↗ |
| K935224 | VOLUME NECK COIL FOR THE GYREX V-DIX | Elscint, Inc. | 1994-06-27 | Traditional | PDF ↗ |
| K930193 | PHILIPS ENDO-CAVITARY MRI COIL | Philips Medical Systems, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K940364 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | Medical Advances, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K934514 | CATCH AND HOLD OPTION FOR INSTASCAN | Advanced Nmr Systems, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K941025 | PHASED ARRAY BREAST COIL | Medical Advances, Inc. | 1994-06-08 | Traditional | PDF ↗ |
| K940874 | MODEL 900GE1500 HEAD/NECK COIL | Medic, Inc. | 1994-06-03 | Traditional | PDF ↗ |
| K940602 | EXTRA LARGE QUAD FLEX SPINE COIL | Hitachi Medical Systems America, Inc. | 1994-05-23 | Traditional | PDF ↗ |
| K935015 | QUADRATURE SMALL EXTREMITY COIL | Magnetic Research, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K940514 | 41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15 | Medical Advances, Inc. | 1994-05-05 | Traditional | PDF ↗ |
| K934538 | MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY | Noise Cancellation Technologies | 1994-04-25 | Traditional | PDF ↗ |
| K935671 | 2D, 3D TOF MR ANGIOGRAPHY | Hitachi Medical Systems America, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K935670 | VERSION 3 OPERATING SYSTEM SOFTWARE | Hitachi Medical Systems America, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K935627 | CP BODY ARRAY/ CP SPINE ARRAY COIL | Siemens Medical Solutions USA, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K935752 | CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS | Siemens Medical Solutions USA, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K935450 | PHASED ARRAY PELVIC COIL | Medical Advances, Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K935369 | FAST SPIN ECHO (FSE) | Resonex, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K933296 | MODEL #310GE1500 WRIST COIL | Medic, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K933295 | MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA | Medic, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K935661 | MAGNETOM OPEN | Siemens Medical Solutions USA, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K935570 | NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM | Resonex, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K935664 | FAST SPIN ECHO | Hitachi Medical Systems America, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K931460 | VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM | General Electric Co. | 1994-03-04 | Traditional | PDF ↗ |
| K932403 | AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN | Medrad, Inc. | 1994-02-24 | Traditional | PDF ↗ |
| K932244 | SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM | Shimadzu Medical Systems | 1994-02-18 | Traditional | PDF ↗ |
| K933018 | MRT-50GP | Toshiba America Mri, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K935084 | INCREASED SAR PACKAGE FOR MRT-150A | Toshiba America Mri, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K932552 | SPORTS MEDICINE QUADRATURE SHOULDER COIL | Magnetic Research, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K930708 | PHILIPS GYROSCAN T5 II RELEASE 3 | Philips Medical Systems, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K934485 | HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION | Hitachi Medical Systems America, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K931298 | SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM | General Electric Co. | 1994-01-18 | Traditional | PDF ↗ |
| K932271 | MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016 | Siemens Medical Solutions USA, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K934719 | EXTRA LARGE QUAD FLEX SPINE COIL | Hitachi Medical Systems America, Inc. | 1994-01-05 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.