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 11 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K903048 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K902044 | MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM | Instrumentarium Imaging, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K902933 | TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) | General Electric Co. | 1990-08-23 | Traditional | PDF ↗ |
| K901952 | MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL | Siemens Medical Solutions USA, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K903319 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | GE Medical Systems | 1990-08-17 | Traditional | PDF ↗ |
| K901888 | PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15 | Medrad, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K902314 | LARGE FLEXIBLE BODY COIL | Toshiba America Mri, Inc. | 1990-08-03 | Traditional | PDF ↗ |
| K902315 | CERVICAL COIL MRT 50A | Toshiba America Mri, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902310 | SOFTWARE RELEASE 4.2P, ACCESS(TM) | Toshiba America Mri, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902316 | KNEE QD COIL MRT 50A | Toshiba America Mri, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K902630 | BILATERAL TMJ COIL | Resonex, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K901730 | GE SIGNA ADVANTAGE | GE Medical Systems | 1990-07-06 | Traditional | PDF ↗ |
| K901980 | MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Summit World Trade Corp. | 1990-06-28 | Traditional | PDF ↗ |
| K901864 | MODEL 4050-21; 5.25 LOOP SHOULDER COIL | Medical Advances, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K901818 | ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63 | Siemens Medical Solutions USA, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K901639 | MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL | Medical Advances, Inc. | 1990-05-14 | Traditional | PDF ↗ |
| K900919 | MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS | Summit World Trade Corp. | 1990-05-14 | Traditional | PDF ↗ |
| K901602 | VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 | Resonex, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K901620 | MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI | Instrumentarium Imaging, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K900026 | BRUKER R28 WHOLE-BODY MR SCANNER | Bruker Medical Imaging, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K901242 | MODEL 2121-64; TMJ SURFACE COIL | Medical Advances, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K901384 | MODEL 6000-21; VOLUME NECK COIL | Medical Advances, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K901305 | MODEL 2121-21, TMJ SURFACE COIL | Medical Advances, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K901241 | THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64 | Medical Advances, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K901092 | MODEL 8010; EXTREMITY SURFACE COIL | Medical Advances, Inc. | 1990-04-05 | Traditional | PDF ↗ |
| K900889 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES | Siemens Medical Solutions USA, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K900725 | RADIO FREQUENCY RECEIVER SUBSYSTEM | Myheal Technologies | 1990-03-23 | Traditional | PDF ↗ |
| K900283 | MRT 50A SOFTWARE RELEASE 9.0 | Toshiba America Mri, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K900727 | MRT 50A JOINT COIL | Toshiba America Mri, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900284 | MRT 50A 150MM CIRCULAR SURFACE COIL | Toshiba America Mri, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K895328 | MAGNETIC RESONANCE SYSTEM MODEL BMT-1100 | Bruker Medical Imaging, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900064 | VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900289 | MRT 50A 100MM CIRCULAR SURFACE COIL | Toshiba America Mri, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900285 | MRT 50A FLEXIBLE BODY COIL | Toshiba America Mri, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900728 | MRT 50A KNEE COIL | Toshiba America Mri, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900288 | MRT 50A BRAIN QD COIL | Toshiba America Mri, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K900286 | MRT 50A SPINE SURFACE COIL | Toshiba America Mri, Inc. | 1990-03-08 | Traditional | PDF ↗ |
| K900287 | MRT 50A CRANIO-CERVICAL COIL | Toshiba America Mri, Inc. | 1990-03-08 | Traditional | PDF ↗ |
| K896419 | MODEL: GYREX VERSION V | Elscint, Inc. | 1990-02-02 | Traditional | PDF ↗ |
| K895629 | MODEL 8100; UPPER EXTREMITY COIL | Medical Advances, Inc. | 1990-02-02 | Traditional | PDF ↗ |
| K896789 | MODEL 6000; VOLUME NECK COIL | Medical Advances, Inc. | 1990-01-23 | Traditional | PDF ↗ |
| K896508 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1990-01-12 | Traditional | PDF ↗ |
| K896309 | MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC | Instrumentarium Imaging, Inc. | 1990-01-12 | Traditional | PDF ↗ |
| K894855 | MODEL 5070; DUAL PLANAR PAIR | Medical Advances, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K896336 | MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A | Medical Advances, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K896647 | GYROVIEW HR HIGH RESOLUTION WORKSTATION | Philips Medical Systems North America, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K895869 | GYROSCAN T5 MOBILE | Philips Medical Systems, Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K895966 | MAGNETOM M, H, 42, 63, 42 SP AND 63 SP | Siemens Medical Solutions USA, Inc. | 1989-11-30 | Traditional | PDF ↗ |
| K894016 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20 | Summit World Trade Corp. | 1989-11-22 | Traditional | PDF ↗ |
| K895794 | GE MR MAX SYSTEM | GE Medical Systems | 1989-11-17 | Traditional | PDF ↗ |
| K894714 | 1989 SOFTWARE REVISION TO THE BMT-1100 | Bruker Medical Imaging, Inc. | 1989-11-15 | Traditional | PDF ↗ |
| K893744 | SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM | Shimadzu Medical Systems | 1989-11-06 | Traditional | PDF ↗ |
| K895151 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1989-10-30 | Traditional | PDF ↗ |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | Diasonics, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K895131 | MODEL 2031 TMJ SURFACE COIL | Medical Advances, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K895221 | ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42 | Siemens Medical Solutions USA, Inc. | 1989-10-03 | Traditional | PDF ↗ |
| K894974 | MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM | Resonex, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K894290 | ACCESS TM | Diasonics, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K893509 | GE SIGNA ADVANTAGE | GE Medical Systems | 1989-08-11 | Traditional | PDF ↗ |
| K893750 | MRT-50A MOBILE | Toshiba Medical Systems | 1989-08-09 | Traditional | PDF ↗ |
| K893640 | SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM | Siemens Medical Solutions USA, Inc. | 1989-08-02 | Traditional | PDF ↗ |
| K893689 | VISION INTEGRATED PERFORMANCE OPTION | Siemens Medical Solutions USA, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K893675 | VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES | Philips Medical Systems (Cleveland), Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K893739 | VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES | Philips Medical Systems (Cleveland), Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K891543 | MAGNAVIEW MOBILE MRI VERSION 110 FHM | Instrumentarium Imaging, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K890092 | HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Health Images, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K891760 | MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED | Bruker Medical Imaging, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893619 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893881 | ACCESS TM | Diasonics, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K891769 | MAGNISCAN 5000 MR SYSTEM | General Electric Co. | 1989-06-15 | Traditional | PDF ↗ |
| K892959 | VERSION 4.2 APPLICATION SOFTWARE | Resonex, Inc. | 1989-06-01 | Traditional | PDF ↗ |
| K891598 | MODEL 2030; 3 TMJ SURFACE COIL | Medical Advances, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K891541 | MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0. | Diasonics, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K892235 | GE SHOULDER SURFACE COIL, CAT. #M1085AN | General Electric Co. | 1989-05-11 | Traditional | PDF ↗ |
| K890855 | MODEL 4041; 4 ANGLED PAIR CRC SURFACE COIL | Medical Advances, Inc. | 1989-05-01 | Traditional | PDF ↗ |
| K890789 | GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Philips Medical Systems North America, Inc. | 1989-04-28 | Traditional | PDF ↗ |
| K890666 | MODEL 3031; CERVICAL SPINE SURFACE COIL | Medical Advances, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K890815 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES | Siemens Medical Solutions USA, Inc. | 1989-04-03 | Traditional | PDF ↗ |
| K885047 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K890394 | MEDRAD SCPD 1000 | Medrad, Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K885223 | RMI SHORT DISTANCE ALIGNMENT DEVICE | Radiation Measurements, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K884816 | ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY | Diasonics, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K883898 | MAGNETOM 42 SP AND MAGNETOM 63 SP | Siemens Medical Solutions USA, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K884484 | MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL | Siemens Medical Solutions USA, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K884607 | MT/S (SOFTWARE RELEASE 3.1) | Diasonics, Inc. | 1988-12-21 | Traditional | PDF ↗ |
| K884606 | MT/S (SPINE TRANSMIT COIL) | Diasonics, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K884743 | TEMPOROMANDIBULAR JOINT COIL (TMJ) | Diasonics, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K884603 | SHOULDER TRANSMIT AND RECEIVE COILS | Diasonics, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K883547 | GE MR MAX SYSTEM | General Electric Co. | 1988-11-30 | Traditional | PDF ↗ |
| K884604 | MT/S CARLSON SPINE COIL, PART # 100-50082500-01 | Diasonics, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K884369 | POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM | General Electric Co. | 1988-11-28 | Traditional | PDF ↗ |
| K884062 | MAGNETOM (M, H, 42, 63) SEQUENCES | Siemens Medical Solutions USA, Inc. | 1988-11-23 | Traditional | PDF ↗ |
| K883994 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1988-11-21 | Traditional | PDF ↗ |
| K883872 | CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL | Siemens Medical Solutions USA, Inc. | 1988-11-21 | Traditional | PDF ↗ |
| K883756 | TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM | Toshiba Medical Systems | 1988-11-14 | Traditional | PDF ↗ |
| K883621 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM | Instrumentarium Corp. | 1988-11-10 | Traditional | PDF ↗ |
| K883699 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 1988-10-31 | Traditional | PDF ↗ |
| K883482 | VISTA MR 2055 HP SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883649 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H | Instrumentarium Corp. | 1988-10-19 | Traditional | PDF ↗ |
| K883648 | BETA 3000M MOBILE NMR IMAGING SYSTEM | Fonar Corp. | 1988-10-19 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.