FDA Product Code
FDA Product Code MOS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 490 records · page 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001582 | LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE | Usa Instruments, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K001303 | BREAST IMMOBILIZATION DEVICE MR-BY 160 | Mri Devices Corp. | 2000-06-20 | Traditional | PDF ↗ |
| K001312 | MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL | Igc-Medical Advances, Inc. | 2000-06-20 | Traditional | PDF ↗ |
| K001713 | HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA | Mri Devices Corp. | 2000-06-14 | Special | PDF ↗ |
| K001331 | SYNERGY HEAD/NECK COIL | Philips Medical Systems North America, Inc. | 2000-06-09 | Traditional | PDF ↗ |
| K001210 | HI-RES 9000 PHASED ARRAY CAROTID COIL | Usa Instruments, Inc. | 2000-06-09 | Traditional | PDF ↗ |
| K001209 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL | Usa Instruments, Inc. | 2000-06-01 | Traditional | PDF ↗ |
| K000993 | LIBERTY 9000 BREAST COIL | Usa Instruments, Inc. | 2000-05-26 | Traditional | PDF ↗ |
| K000549 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 2000-04-20 | Traditional | PDF ↗ |
| K000437 | INTERVENTIONAL BODY COIL | Usa Instruments, Inc. | 2000-04-14 | Traditional | PDF ↗ |
| K000345 | MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES | Medical Advances, Inc. | 2000-04-11 | Traditional | PDF ↗ |
| K000935 | KFA-63 KNEE AND FOOT ARRAY | Mri Devices Corp. | 2000-04-07 | Special | PDF ↗ |
| K994436 | SURGI-VISION ESOPHAGEAL STYLET COIL | Surgi-Vision, Inc. | 2000-03-14 | Traditional | PDF ↗ |
| K000589 | MODEL 445SI-64E QUADRATURE WRIST COIL | Igc-Medical Advances, Inc. | 2000-03-14 | Traditional | PDF ↗ |
| K994378 | AIRIS II | Hitachi Medical Systems America, Inc. | 2000-03-07 | Traditional | PDF ↗ |
| K000002 | MAGNA 5000 PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2000-02-23 | Traditional | PDF ↗ |
| K994345 | MAGNA 5000 PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2000-02-14 | Traditional | PDF ↗ |
| K993898 | KAC-63 KNEE ARRAY COIL | Mri Devices Corp. | 2000-02-04 | Traditional | PDF ↗ |
| K994315 | CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM | Siemens Medical Solutions USA, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K994042 | SHARP 9000 PHASED ARRAY BRAIN COIL | Usa Instruments, Inc. | 2000-01-31 | Traditional | PDF ↗ |
| K994040 | PHASED ARRAY KNEE AND FOOT COIL | Usa Instruments, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K993776 | OBC-300 BREAST ARRAY COIL | Mri Devices Corp. | 1999-12-03 | Special | PDF ↗ |
| K993819 | QWH-300 WRIST ARRAY COIL | Mri Devices Corp. | 1999-12-03 | Special | PDF ↗ |
| K993780 | QSC-300 SHOULDER ARRAY COILS | Mri Devices Corp. | 1999-11-26 | Special | PDF ↗ |
| K993719 | KAC-300 KNEE ARRAY COIL | Mri Devices Corp. | 1999-11-26 | Special | PDF ↗ |
| K993477 | HRW WRIST ARRAY COIL | Mri Devices Corp. | 1999-11-01 | Special | PDF ↗ |
| K993279 | QSC-085 SHOULDER ARRAY COIL | Mri Devices Corp. | 1999-10-15 | Special | PDF ↗ |
| K993233 | OBC-085 BREAST ARRAY COIL | Mri Devices Corp. | 1999-10-15 | Special | PDF ↗ |
| K993235 | QWH-085 WRIST ARRAY COIL | Mri Devices Corp. | 1999-10-15 | Special | PDF ↗ |
| K992650 | AIRIS, AIRIS II | Hitachi Medical Systems America, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K992193 | ENDO-ESOPHAGEAL MR COIL | Surgi-Vision, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K991724 | QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 | Medical Advances, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K991765 | SYNERGY SHOULDER COIL | Philips Medical Systems North America, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K991740 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K991434 | QUADRATURE WRIST COIL, MODEL 445PH-64 | Medical Advances, Inc. | 1999-07-06 | Traditional | PDF ↗ |
| K991113 | `INEAR WRIST COIL, MODEL 440GE-09 | Medical Advances, Inc. | 1999-06-10 | Traditional | PDF ↗ |
| K991115 | LINEAR SHOULDER COIL, MODEL 414GE-09 | Medical Advances, Inc. | 1999-06-08 | Traditional | PDF ↗ |
| K991057 | EXTRA LARGE BODY COIL FOR OPART (MRT-600) | Toshiba America Mri, Inc. | 1999-05-20 | Traditional | PDF ↗ |
| K990007 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 1999-04-01 | Traditional | PDF ↗ |
| K983139 | SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL | GE Medical Systems | 1999-02-19 | Traditional | PDF ↗ |
| K984588 | PHASED ARRAY FLEXIBLE CARDIAC COIL | Philips Medical Systems (Cleveland), Inc. | 1999-02-08 | Traditional | PDF ↗ |
| K984257 | MEDRAD PHASED ARRAY NEUROVASCULAR COIL | Medrad, Inc. | 1999-01-25 | Traditional | PDF ↗ |
| K984159 | MEDRAD QUADRATURE CTL ARRAY COIL | Medrad, Inc. | 1999-01-12 | Traditional | PDF ↗ |
| K984272 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 | Hitachi Medical Systems America, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K984278 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II | Hitachi Medical Systems America, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K982978 | MODEL 340GE-21C QUADRATURE BRAIN COIL | Medical Advances, Inc. | 1998-11-23 | Traditional | PDF ↗ |
| K982972 | SIGNA PROFILE SMALL HEAD COIL | GE Medical Systems | 1998-11-16 | Traditional | PDF ↗ |
| K983143 | MARK 5000 PHASED ARRAY SHOULDER COIL | Usa Instruments, Inc. | 1998-11-16 | Traditional | PDF ↗ |
| K982921 | MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA | Medrad, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K982919 | MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC | Medrad, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K982916 | MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC | Medrad, Inc. | 1998-10-29 | Traditional | PDF ↗ |
| K982772 | SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL | Ge Medical Systems, Inc. | 1998-10-15 | Traditional | PDF ↗ |
| K983222 | PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 | Medical Advances, Inc. | 1998-10-08 | Traditional | PDF ↗ |
| K983109 | MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY | Medical Advances, Inc. | 1998-10-06 | Traditional | PDF ↗ |
| K982496 | QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D | Medical Advances, Inc. | 1998-09-18 | Traditional | PDF ↗ |
| K982339 | FLOW 7000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 1998-09-04 | Traditional | PDF ↗ |
| K981959 | OUTLOOK LARGE PHASED ARRAY NECK COIL | Philips Medical Systems (Cleveland), Inc. | 1998-07-31 | Traditional | PDF ↗ |
| K981406 | CERVIX COIL LATEX SHEATH | Philips Medical Systems (Cleveland), Inc. | 1998-07-16 | Traditional | PDF ↗ |
| K981094 | MEDRAD NEUROVASCULAR COIL | Medrad, Inc. | 1998-06-18 | Traditional | PDF ↗ |
| K980691 | AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K974438 | MEDRAD ATD-T INTERFACE DEVICE | Medrad, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K980157 | PREMIER 7000 CTL SPINE COIL | Usa Instruments, Inc. | 1998-04-13 | Traditional | PDF ↗ |
| K974308 | MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY | Medrad, Inc. | 1998-01-27 | Traditional | PDF ↗ |
| K973787 | MEDRAD 1.5T EXTREMITY ARRAY | Medrad, Inc. | 1997-12-30 | Traditional | PDF ↗ |
| K973630 | CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | Elscint, Inc. | 1997-09-15 | Traditional | PDF ↗ |
| K972296 | MAGNETIC RESONANCE DIAGNOSTIC SYSTEM | Ge Medical Systems, Inc. | 1997-09-15 | Traditional | PDF ↗ |
| K972205 | ALPHA 7000 QUADRATURE WRIST COIL | Usa Instruments, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972340 | INSIGHT 7000 PHASED ARRAY TORSO COIL | Usa Instruments, Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K971667 | CARDIAC PHASED ARRAY COIL | GE Medical Systems | 1997-07-23 | Traditional | PDF ↗ |
| K964969 | SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) | GE Medical Systems | 1997-06-26 | Traditional | PDF ↗ |
| K971246 | LEO 7000 QUADRATURE KNEE COIL | Usa Instruments, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K971016 | MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) | Hitachi Medical Systems America, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K970868 | MODEL HNC NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 1997-06-06 | Traditional | PDF ↗ |
| K964820 | MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A | Us Asia Instruments, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K964813 | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: | Medical Advances, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K964668 | MODELS EXL AND EXS EXTREMITY COIL SET | Mri Devices Corp. | 1997-02-18 | Traditional | PDF ↗ |
| K964678 | PHASED ARRAY NECK COIL | Philips Medical Systems (Cleveland), Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K964854 | MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL | Medrad, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER | Contour Fabricators, Inc. | 1997-01-30 | Traditional | PDF ↗ |
| K963356 | PHASED ARRAY SHOULDER COIL | Philips Medical Systems (Cleveland), Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K961628 | MINI FLEX COIL | W. L. Gore & Associates, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K961525 | ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) | Mri Devices Corp. | 1996-09-05 | Traditional | PDF ↗ |
| K961391 | FLEXART QD HEAD/NECK COIL | Toshiba America Mri, Inc. | 1996-07-09 | Traditional | PDF ↗ |
| K954952 | MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL | Medrad, Inc. | 1996-03-13 | Traditional | PDF ↗ |
| K955626 | MEDRAD/HITACHI BREAST IMAGING SURFACE COIL | Medrad, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K954190 | MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL | Medical Advances, Inc. | 1995-11-20 | Traditional | PDF ↗ |
| K953595 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | GE Medical Systems | 1995-10-27 | Traditional | PDF ↗ |
| K952944 | MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL | Medical Advances, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K950966 | MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE | Medical Advances, Inc. | 1995-07-26 | Traditional | PDF ↗ |
Product code MOS · Class II · Radiology. Data: openFDA.