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 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030317 | MODEL 1300GE-64: PEDIATRIC POSITIONER | Midwest Rf, LLC | 2003-03-25 | Traditional | PDF ↗ |
| K030495 | 3.0T TORSO PHASED ARRAY COIL | Ge Medical Systems, Inc. | 2003-03-05 | Traditional | PDF ↗ |
| K030042 | PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-02-24 | Traditional | PDF ↗ |
| K023929 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Advanced Imaging Research, Inc. | 2003-02-21 | Traditional | PDF ↗ |
| K023982 | LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL | Usa Instruments, Inc. | 2003-02-21 | Traditional | PDF ↗ |
| K023848 | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: | Igc-Medical Advances, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K024187 | SPIRIT III TOTALSENSE CARDIAC COIL | Usa Instruments, Inc. | 2003-02-04 | Traditional | PDF ↗ |
| K022863 | HTS COIL | Jockey Club Mri Engineering Center | 2003-02-04 | Traditional | PDF ↗ |
| K023650 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL | Usa Instruments, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K024354 | PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS | Mri Devices Corp. | 2003-01-09 | Special | PDF ↗ |
| K024209 | QWH-250-PAN WRIST ARRAY COIL | Mri Devices Corp. | 2003-01-09 | Special | PDF ↗ |
| K024352 | HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM | Mri Devices Corp. | 2003-01-09 | Special | PDF ↗ |
| K024208 | OBC-250-PAN BREAST ARRAY COIL | Mri Devices Corp. | 2003-01-07 | Special | PDF ↗ |
| K023247 | CHAMPION 5000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2002-12-23 | Traditional | PDF ↗ |
| K023084 | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL | Medical Advances, Inc. | 2002-12-16 | Traditional | PDF ↗ |
| K023571 | 6 CHANNEL BODY COIL | Siemens Medical Systems, Inc. | 2002-11-20 | Special | PDF ↗ |
| K023679 | GORE 3.0T TORSO ARRAY | W. L. Gore & Associates, Inc. | 2002-11-18 | Traditional | PDF ↗ |
| K023596 | MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL | Medrad, Inc. | 2002-11-08 | Special | PDF ↗ |
| K023442 | EXTRA LARGE BODY COIL | GE Medical Systems | 2002-11-05 | Special | PDF ↗ |
| K022007 | LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES | Usa Instruments, Inc. | 2002-11-04 | Traditional | PDF ↗ |
| K022582 | EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL | Usa Instruments, Inc. | 2002-10-22 | Traditional | PDF ↗ |
| K023164 | BBC-63-GE BREAST ARRAY COIL | Mri Devices Corp. | 2002-10-11 | Special | PDF ↗ |
| K022910 | QSC-63-INT SHOULDER ARRAY COIL SET | Mri Devices Corp. | 2002-10-03 | Special | PDF ↗ |
| K022883 | HRK-63 KNEE ARRAY COIL | Mri Devices Corp. | 2002-09-27 | Special | PDF ↗ |
| K022669 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | GE Medical Systems | 2002-09-06 | Special | PDF ↗ |
| K022720 | CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL | Mri Devices Corp. | 2002-09-06 | Special | PDF ↗ |
| K022588 | HRW-63-INT WRIST ARRAY COIL | Mri Devices Corp. | 2002-09-04 | Special | PDF ↗ |
| K022487 | MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL | Mri Devices Corp. | 2002-08-23 | Special | PDF ↗ |
| K022488 | MODEL OBC-63 BREAST ARRAY COIL | Mri Devices Corp. | 2002-08-23 | Special | PDF ↗ |
| K021751 | ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM | Hitachi Medical Systems America, Inc. | 2002-08-15 | Abbreviated | PDF ↗ |
| K021631 | ISA-21 INTERVENTIONAL SPINE ARRAY COIL | Mri Devices Corp. | 2002-08-13 | Traditional | PDF ↗ |
| K022372 | HRH-127-8 HEAD ARRAY COIL | Mri Devices Corp. | 2002-08-13 | Special | PDF ↗ |
| K022395 | 1.5T SCANMED PV ARRAY | Medic, Inc. | 2002-08-13 | Special | PDF ↗ |
| K021330 | MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL | Usa Instruments, Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K021141 | MILLENNIUM 5000 MEUROVASCULAR COIL | Usa Instruments, Inc. | 2002-06-27 | Traditional | PDF ↗ |
| K021433 | MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL | Medical Advances, Inc. | 2002-06-13 | Traditional | PDF ↗ |
| K021575 | OBC-127 BREAST ARRAY COIL | Mri Devices Corp. | 2002-06-12 | Special | PDF ↗ |
| K021570 | HNC-127-TRIO NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2002-06-12 | Special | PDF ↗ |
| K020850 | GPF-29 GENERAL PURPOSE COIL SET | Mri Devices Corp. | 2002-06-06 | Traditional | PDF ↗ |
| K020993 | ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) | Magna-Lab, Inc. | 2002-05-21 | Traditional | PDF ↗ |
| K020790 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL | Surgi-Vision, Inc. | 2002-05-21 | Traditional | PDF ↗ |
| K021262 | MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL | Usa Instruments, Inc. | 2002-05-21 | Traditional | PDF ↗ |
| K020601 | FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL | Odin Medical Technologies , Ltd. | 2002-04-24 | Traditional | PDF ↗ |
| K020495 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL | Surgi-Vision, Inc. | 2002-04-23 | Traditional | PDF ↗ |
| K020606 | NVA-63-8 NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2002-03-13 | Special | PDF ↗ |
| K013854 | MARK 5000 QUADRATURE SHOULDER COIL | Usa Instruments, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K014086 | CTL BODY / SPINE ARRAY COIL | Usa Instruments, Inc. | 2002-02-05 | Traditional | PDF ↗ |
| K020036 | EXS-63 SMALL EXTREMITY ARRAY COIL | Mri Devices Corp. | 2002-02-01 | Special | PDF ↗ |
| K013985 | MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX | Machnet BV | 2002-02-01 | Traditional | PDF ↗ |
| K013595 | PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K013594 | BODY ARRAY COIL | Usa Instruments, Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K013894 | TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T | Philips Medical Systems North America, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013592 | EXTREMITY COIL | Usa Instruments, Inc. | 2002-01-08 | Traditional | PDF ↗ |
| K013514 | PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL | Mri Devices Corp. | 2002-01-02 | Traditional | PDF ↗ |
| K013541 | SHOULDER COIL | Usa Instruments, Inc. | 2001-12-14 | Traditional | PDF ↗ |
| K013528 | CRYSTAL 5000 PHASES ARRAY TMJ COIL | Usa Instruments, Inc. | 2001-12-13 | Traditional | PDF ↗ |
| K011683 | NURVO 9000 ENDOCAVITARY COILS | Usa Instruments, Inc. | 2001-12-10 | Traditional | PDF ↗ |
| K013810 | CARDIOVASCULAR ARRAY | W. L. Gore & Associates, Inc. | 2001-11-27 | Traditional | PDF ↗ |
| K013602 | HNC-63-INT NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2001-11-20 | Special | PDF ↗ |
| K013508 | HRH-127-ALLEGRA HEAD ARRAY COIL | Mri Devices Corp. | 2001-11-20 | Special | PDF ↗ |
| K012491 | MACHNET CAROTIDS COIL ARRAY ASSEMBLY | Machnet BV | 2001-10-24 | Traditional | PDF ↗ |
| K013159 | HRH-63-8 HEAD ARRAY COIL | Mri Devices Corp. | 2001-10-16 | Special | PDF ↗ |
| K013322 | HAC-420 HEAD ARRAY COIL | Mri Devices Corp. | 2001-10-16 | Special | PDF ↗ |
| K013099 | MODIFICATION TO: QWH-420 WRIST ARRAY COIL | Mri Devices Corp. | 2001-09-25 | Special | PDF ↗ |
| K011781 | INTERCEPT-URETHRAL MICROCOIL | Surgi-Vision, Inc. | 2001-08-31 | Traditional | PDF ↗ |
| K012728 | E-SCAN MRI SYSTEM | Biosound Esaote, Inc. | 2001-08-29 | Special | PDF ↗ |
| K012353 | HNC-127 NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2001-08-14 | Special | PDF ↗ |
| K011608 | MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL | Medical Advances, Inc. | 2001-08-14 | Traditional | PDF ↗ |
| K010802 | CARDIAC VIEW, MODEL 2001 | Magna Lab, Inc. | 2001-06-08 | Traditional | PDF ↗ |
| K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL | Usa Instruments, Inc. | 2001-05-30 | Traditional | PDF ↗ |
| K003505 | KFA-127 KNEE, FOOT AND ANKLE ARRAY | Mri Devices Corp. | 2001-05-25 | Traditional | PDF ↗ |
| K010513 | CARDIAC VIEW, MODEL 2001 | Magna-Lab, Inc. | 2001-05-21 | Traditional | PDF ↗ |
| K010730 | MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2001-05-16 | Traditional | PDF ↗ |
| K010074 | MODEL 455GE PHASED ARRAY WRIST COIL | Medical Advances, Inc. | 2001-04-03 | Traditional | PDF ↗ |
| K003613 | 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL | GE Medical Systems | 2001-04-03 | Traditional | PDF ↗ |
| K003946 | SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL | GE Medical Systems | 2001-02-27 | Traditional | PDF ↗ |
| K010140 | HRH-127 HEAD ARRAY COIL | Mri Devices Corp. | 2001-02-22 | Traditional | PDF ↗ |
| K003436 | SURGI-VISION GUIDEWIRE COIL | Surgi-Vision, Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K003655 | PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL | Mri Devices Corp. | 2001-02-02 | Traditional | PDF ↗ |
| K001097 | ACTIVE ARRAY CATHETER, MODEL CS-2000 | Image-Guided Neurologics, Inc. | 2001-01-18 | Traditional | PDF ↗ |
| K003386 | SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 | Midwest Rf, LLC | 2000-12-28 | Traditional | PDF ↗ |
| K003097 | BRAIN COIL, MODEL 9800GE-64 | Midwest Rf, LLC | 2000-12-28 | Traditional | PDF ↗ |
| K003685 | MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL | Medical Advances, Inc. | 2000-12-22 | Traditional | PDF ↗ |
| K003366 | MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL | Igc-Medical Advances, Inc. | 2000-12-22 | Traditional | PDF ↗ |
| K003144 | MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL | Medical Advances, Inc. | 2000-12-13 | Traditional | PDF ↗ |
| K002916 | SURGI-VISION PROSTATE COIL | Surgi-Vision, Inc. | 2000-11-28 | Traditional | PDF ↗ |
| K002860 | MODEL 6900GE-64: C-SPINE ARRAY | Midwest Rf, LLC | 2000-11-22 | Traditional | PDF ↗ |
| K002864 | MODEL 6600GE-64: TRAMA NECK ARRAY | Midwest Rf, LLC | 2000-11-21 | Traditional | PDF ↗ |
| K002774 | HRH-63 HEAD ARRAY COIL | Mri Devices Corp. | 2000-11-16 | Traditional | PDF ↗ |
| K003331 | QWH-149 WRIST ARRAY COIL | Mri Devices Corp. | 2000-11-08 | Special | PDF ↗ |
| K003340 | OBC-149 BREAST ARRAY COIL | Mri Devices Corp. | 2000-11-08 | Special | PDF ↗ |
| K002483 | POWER 5000 GENERAL PURPOSE COIL | Usa Instruments, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K002522 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K002482 | VISION 9000 PHASED ARRAY TORSO COIL | Usa Instruments, Inc. | 2000-10-17 | Traditional | PDF ↗ |
| K002345 | SURGI-VISION URETHRAL COIL | Surgi-Vision, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K002602 | OBC-63 MEBREAST ARRAY COIL | Mri Devices Corp. | 2000-09-05 | Special | PDF ↗ |
| K002539 | OBC-096 BREAST ARRAY COIL | Mri Devices Corp. | 2000-08-30 | Special | PDF ↗ |
| K001946 | NEUROVASCULAR ARRAY COIL | Ge Medical Systems, Inc. | 2000-08-30 | Traditional | PDF ↗ |
| K001944 | HAC-300 HEAD ARRAY COIL | Mri Devices Corp. | 2000-08-14 | Traditional | PDF ↗ |
| K001870 | MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL | Usa Instruments, Inc. | 2000-08-14 | Traditional | PDF ↗ |
Product code MOS · Class II · Radiology. Data: openFDA.