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 9 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934212 | FAST SPIN ECHO | Hitachi Medical Systems America, Inc. | 1993-12-27 | Traditional | PDF ↗ |
| K934499 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | GE Medical Systems | 1993-12-23 | Traditional | PDF ↗ |
| K932091 | PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL | Magnetic Research, Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K931656 | MERIT | Picker International | 1993-12-14 | Traditional | PDF ↗ |
| K933356 | MERIT | Philips Medical Systems (Cleveland), Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K931454 | IMAGEACCESS SYSTEM | Image Premastering Services, Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K932644 | PHILIPS GYROSCAN TN5 & TN5 LITE | Philips Medical Systems, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K932645 | PHILIPS GYROSCAN TN 15 | Philips Medical Systems, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K925858 | OE 1.5 SI | Otsuka Electronics | 1993-12-02 | Traditional | PDF ↗ |
| K934396 | QUADRATURE LOWER EXTREMITY COIL | Medical Advances, Inc. | 1993-11-24 | Traditional | PDF ↗ |
| K933659 | MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL | Medic, Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K931544 | 1.5T EDGE AND 1.0T VISTA SYSTEMS | Philips Medical Systems (Cleveland), Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K933835 | 0.5T ASSET SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K933658 | MODEL 300GE1500 SHOULDER COIL | Medic, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K933645 | ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 | Hitachi Medical Systems America, Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930709 | PHILIPS GYROSCAN ACS-II RELEASE 3 | Philips Medical Systems, Inc. | 1993-11-08 | Traditional | PDF ↗ |
| K931392 | ECG GATING UNIT | Resonex, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K933297 | MODEL #510GE1500 LIVER ARRAY COIL | Medic, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K930960 | ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY | Toshiba America Mri, Inc. | 1993-11-01 | Traditional | PDF ↗ |
| K926275 | PHILIPS MRI BREAST COIL | Philips Medical Systems, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K932344 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES | Siemens Medical Solutions USA, Inc. | 1993-10-25 | Traditional | PDF ↗ |
| K926001 | MRT-50A, MRT-150A | Toshiba America Mri, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K925985 | GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 | Elscint, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K931022 | ARTOSCAN | Biosound, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K930779 | MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15 | Medrad, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K925286 | MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE | Toshiba America Mri, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K932693 | EDGE SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K925597 | SNR-3000 UPGRADE RECEIVER COILS | Magnetic Resonance Plus, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K930544 | MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15 | Medrad, Inc. | 1993-09-29 | Traditional | PDF ↗ |
| K930674 | MODEL 640GE-64: QUADRATURE PELVIC COIL | Medical Advances, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K932374 | MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K932375 | MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K930811 | MODIFIED BODY HELMHOLTZ COIL | Siemens Medical Solutions USA, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K932338 | MAGNETOM P8 | Siemens Medical Solutions USA, Inc. | 1993-08-30 | Traditional | PDF ↗ |
| K932292 | AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS | Medrad, Inc. | 1993-08-26 | Traditional | PDF ↗ |
| K930122 | MODEL 600GE-64: BILATERAL BREAST COIL | Medical Advances, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K930045 | MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL | Mri Devices Corp. | 1993-07-26 | Traditional | PDF ↗ |
| K926571 | MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15 | Medrad, Inc. | 1993-07-20 | Traditional | PDF ↗ |
| K931008 | MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL | Mri Devices Corp. | 1993-06-18 | Traditional | PDF ↗ |
| K930991 | BILATERAL TEMPORAL MANDIBULAR JOINT COIL | Magnetic Research, Inc. | 1993-06-18 | Traditional | PDF ↗ |
| K922846 | MRH-1500 | Hitachi Medical Systems America, Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K924605 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | General Electric Co. | 1993-05-21 | Traditional | PDF ↗ |
| K925987 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K926416 | SAT PAD(TM) | Alliance Pharmaceutical Corp. | 1993-05-19 | Traditional | PDF ↗ |
| K925029 | MRINNERVU ENDORECTAL PROSTATE COIL | Medrad, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924921 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-17 | Traditional | PDF ↗ |
| K921891 | SILENT SCAN | Avotec, Inc. | 1993-05-13 | Traditional | PDF ↗ |
| K923581 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-03 | Traditional | PDF ↗ |
| K924472 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1993-05-03 | Traditional | PDF ↗ |
| K926171 | MRT-150A, QD SPINE COIL | Toshiba America Mri, Inc. | 1993-04-27 | Traditional | PDF ↗ |
| K923944 | PHILIPS GYROVIEW HR - RELEASE 2 | Philips Medical Systems North America, Inc. | 1993-04-27 | Traditional | PDF ↗ |
| K924808 | MRT-50A SUPER | Toshiba America Mri, Inc. | 1993-04-27 | Traditional | PDF ↗ |
| K926397 | FAST SPIN ECHO MEASURING FUNCTION | Hitachi Medical Systems America, Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K923984 | SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM | Shimadzu Medical Systems | 1993-03-16 | Traditional | PDF ↗ |
| K925009 | 2D TOF ANGIOGRAHY MEASURING FUNCTION | Hitachi Medical Systems America, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K925845 | VISTA HP/HPQ SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K924489 | SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST | Siemens Medical Solutions USA, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K925107 | SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM | Shimadzu Medical Systems | 1993-01-15 | Traditional | PDF ↗ |
| K923870 | 3DTOF MRA | Resonex, Inc. | 1993-01-12 | Traditional | PDF ↗ |
| K924756 | MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL | Siemens Medical Solutions USA, Inc. | 1992-12-30 | Traditional | PDF ↗ |
| K923423 | QUADATURE HEAD/NECK/VASCULAR COIL | Medical Advances, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K924653 | MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL | Mri Devices Corp. | 1992-12-24 | Traditional | PDF ↗ |
| K921653 | VECTRA MAGNETIC RESONANCE SYSTEM | General Electric Co. | 1992-12-24 | Traditional | PDF ↗ |
| K923140 | MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL | Hitachi Medical Systems America, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K924479 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES | Siemens Medical Solutions USA, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K924426 | MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG | Siemens Medical Solutions USA, Inc. | 1992-12-18 | Traditional | PDF ↗ |
| K924349 | GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP | General Electric Co. | 1992-11-27 | Traditional | PDF ↗ |
| K922470 | IES, IMAGE ENHANCEMENT SYSTEM | Open Mri, Inc. | 1992-11-27 | Traditional | PDF ↗ |
| K923025 | SIGNA BREAST COIL AND ARRAY ACCESSORY | GE Medical Systems | 1992-11-27 | Traditional | PDF ↗ |
| K924154 | KINEMATIC MRI MOVIEMAKER | Resonex, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K921940 | MRT-35(TM) | Toshiba America Mri, Inc. | 1992-11-10 | Traditional | PDF ↗ |
| K921941 | SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT | General Electric Co. | 1992-11-09 | Traditional | PDF ↗ |
| K923948 | SAT PAD | Alliance Pharmaceutical Corp. | 1992-11-06 | Traditional | PDF ↗ |
| K920578 | PHILIPS GYROSCAN T5 SERIES II | Philips Medical Systems North America, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K920791 | GYROSCAN S15/ACS-II | Philips Medical Systems, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K923881 | QUADRATURE CERVICAL CONTOUR COIL | Magnetic Research, Inc. | 1992-11-05 | Traditional | PDF ↗ |
| K923823 | 3D IMAGING | Resonex, Inc. | 1992-10-30 | Traditional | PDF ↗ |
| K923897 | A BREAST COIL FOR THE GYREX 2T-DIX | Elscint, Inc. | 1992-10-21 | Traditional | PDF ↗ |
| K923615 | VISTA HPQ SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1992-10-09 | Traditional | PDF ↗ |
| K923352 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1992-10-06 | Traditional | PDF ↗ |
| K923264 | GENERAL PURPOSE FLEX COIL | General Electric Co. | 1992-09-30 | Traditional | PDF ↗ |
| K923022 | INSTRUMENTARIUM MEGA4 HT | Instrumentarium Imaging, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K922798 | QD WHOLE BODY COIL, MRT-150A | Toshiba America Mri, Inc. | 1992-09-14 | Traditional | PDF ↗ |
| K922677 | MAGNETIZATION TRANSFER CONTRAST | Resonex, Inc. | 1992-09-04 | Traditional | PDF ↗ |
| K923010 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | 1992-08-25 | Traditional | PDF ↗ |
| K920227 | QUADRATURE SHOULDER CONTOUR COIL | Magnetic Research, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K920714 | VISTA HPQ SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K921413 | MRT-50 | Toshiba America Mri, Inc. | 1992-08-14 | Traditional | PDF ↗ |
| K920204 | INSTASCAN | Advanced Nmr Systems, Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K920441 | 3D TOF ANGIOGRAPHY MEASURING FUNCTION | Hitachi Medical Systems America, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K922006 | QQUADRATURE LUMBAR CONTOUR COIL | Magnetic Research, Inc. | 1992-07-29 | Traditional | PDF ↗ |
| K922000 | MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL | Mri Devices Corp. | 1992-07-28 | Traditional | PDF ↗ |
| K921881 | VISTA HPQ SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1992-07-17 | Traditional | PDF ↗ |
| K921720 | MRT-50A QD SPINE COIL | Toshiba America Mri, Inc. | 1992-07-16 | Traditional | PDF ↗ |
| K920096 | MRT-150 QD KNEE COIL | Toshiba America Mri, Inc. | 1992-07-10 | Traditional | PDF ↗ |
| K920543 | MRI OE 1.5 SI | Otsuka Electronics | 1992-07-10 | Traditional | PDF ↗ |
| K920789 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K920254 | COILS FOR RX4000 & RX5000 MRI SYSTEMS | Resonex, Inc. | 1992-06-22 | Traditional | PDF ↗ |
| K921609 | VISTA HP/HPQ SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1992-06-15 | Traditional | PDF ↗ |
| K920098 | ACCESS QD HEAD COIL | Toshiba America Mri, Inc. | 1992-06-09 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.