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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072935 | SPEEDER 1.5T WRIST ARRAY COIL | Quality Electrodynamics | 2007-10-31 | Traditional | PDF ↗ |
| K072931 | MC 3003G-32R HEAD COIL | Mr Instruments, Inc. | 2007-10-30 | Traditional | PDF ↗ |
| K071966 | 1.5T MRGFUS PELVIC COIL | Insightec-Txsonics, Inc. | 2007-09-05 | Traditional | PDF ↗ |
| K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL | Shanghai Chenguang Medical Technologies Co, Ltd. | 2007-07-23 | Traditional | PDF ↗ |
| K071882 | MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, | Shanghai Chenguang Medical Technologies Co, Ltd. | 2007-07-18 | Traditional | PDF ↗ |
| K071534 | CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS | Confirma, Inc. | 2007-07-09 | Traditional | PDF ↗ |
| K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | Neocoil | 2007-06-28 | Traditional | PDF ↗ |
| K071179 | NORAS OR HEAD HOLDER | Siemens Medical Solutions USA, Inc. | 2007-06-13 | Traditional | PDF ↗ |
| K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | Neocoil | 2007-05-22 | Traditional | PDF ↗ |
| K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL | Neocoil | 2007-04-11 | Traditional | PDF ↗ |
| K070629 | FLEX AND LOOP COIL SET 1.5 T | Siemens Medical Solutions | 2007-03-26 | Traditional | PDF ↗ |
| K063513 | ECHELON MR-RCC-150 CARDIAC COIL | Hitachi Medical Systems America, Inc. | 2006-12-12 | Abbreviated | PDF ↗ |
| K063342 | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS | Medrad, Inc. | 2006-11-30 | Special | PDF ↗ |
| K063373 | FLEX LOOP COIL SET 3T | Siemens AG | 2006-11-17 | Traditional | PDF ↗ |
| K062767 | CTL-63 AND CTL-128 SPINE ARRAY COILS | Invivo Corporation | 2006-10-13 | Special | PDF ↗ |
| K062556 | ECHELON SHOULDER COIL | Hitachi Medical Systems America, Inc. | 2006-10-05 | Abbreviated | PDF ↗ |
| K061950 | HHF1 ECHELON MULTI-PURPOSE COIL | Hitachi Medical Systems America, Inc. | 2006-08-18 | Abbreviated | PDF ↗ |
| K061715 | MRGFUS GENERAL PURPOSE AND BREAST COIL | Insightec Txsonics, Inc. | 2006-07-28 | Traditional | PDF ↗ |
| K061952 | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 | Invivo | 2006-07-28 | Special | PDF ↗ |
| K061281 | INSIGHT HEAD COIL | Insight Neuroimaging Systems, LLC | 2006-06-19 | Traditional | PDF ↗ |
| K061170 | 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 | Resonance Innovations, LLC | 2006-05-25 | Special | PDF ↗ |
| K060758 | OR HEAD COIL 1.5 T | Siemens Medical Solutions USA, Inc. | 2006-05-05 | Traditional | PDF ↗ |
| K060873 | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS | Sentinelle Medical, Inc. | 2006-04-14 | Traditional | PDF ↗ |
| K060689 | 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL | Resonance Innovations, LLC | 2006-03-31 | Special | PDF ↗ |
| K060547 | ACCESS BREAST COIL 4/SMS | Confirma, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K060401 | MEDRAD 3.0T ECOIL IMAGING SYSTEM | Medrad, Inc. | 2006-03-15 | Special | PDF ↗ |
| K053042 | MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE | Medrad, Inc. | 2005-11-17 | Special | PDF ↗ |
| K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS | Invivo Corporation | 2005-11-16 | Special | PDF ↗ |
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY | Usa Instruments, Inc. | 2005-11-09 | Special | PDF ↗ |
| K052704 | MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE | Invivo Corp. | 2005-11-03 | Traditional | PDF ↗ |
| K052827 | MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS | Medrad, Inc. | 2005-11-01 | Special | PDF ↗ |
| K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A | Invivo Corp. | 2005-10-12 | Special | PDF ↗ |
| K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | Usa Instruments, Inc. | 2005-10-07 | Special | PDF ↗ |
| K052584 | 1.5T 12 CHANNEL BODY ARRAY | Usa Instruments, Inc. | 2005-10-07 | Special | PDF ↗ |
| K052585 | 3T HD BREAST ARRAY | Usa Instruments, Inc. | 2005-10-04 | Special | PDF ↗ |
| K052045 | ACCESS BREAST COIL | Confirma, Inc. | 2005-08-24 | Traditional | PDF ↗ |
| K052200 | TEM 3000 HEAD COIL | Mr Instruments, Inc. | 2005-08-19 | Traditional | PDF ↗ |
| K052077 | G-SCAN CERVICAL SPINE COIL | Esaote, S.p.A. | 2005-08-16 | Special | PDF ↗ |
| K051618 | SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 | Midwest Rf, LLC | 2005-08-02 | Traditional | PDF ↗ |
| K051763 | QD KNEE/FOOT COIL, MODEL MJQJ-147A | Toshiba America Medical Systems, In.C | 2005-07-14 | Traditional | PDF ↗ |
| K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES | Usa Instruments, Inc. | 2005-06-28 | Special | PDF ↗ |
| K051512 | CAC-127-8 CARDOAC ARRAY COIL | Invivo Corp. | 2005-06-28 | Traditional | PDF ↗ |
| K051349 | 3.0T PROSTATE IMAGING SYSTEM | Medrad, Inc. | 2005-06-23 | Special | PDF ↗ |
| K050622 | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL | Mri Devices Corporation | 2005-04-08 | Special | PDF ↗ |
| K050621 | NVA-127-8-A NEUROVASCULAR ARRAY COIL | Mri Devices Corporation | 2005-04-07 | Special | PDF ↗ |
| K050514 | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS | Mri Devices Corporation | 2005-03-25 | Traditional | PDF ↗ |
| K050476 | CORDLESS COIL | Siemens Medical Solution, Inc. USA | 2005-03-25 | Traditional | PDF ↗ |
| K050307 | AIRIS ELITE RAPID BODY COIL | Hitachi Medical Systems America, Inc. | 2005-02-28 | Abbreviated | PDF ↗ |
| K050299 | HRK-123 KNEE ARRAY COIL | Mri Devices Corporation | 2005-02-24 | Special | PDF ↗ |
| K042718 | 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA | Siemens Medi Cal Solutions, Inc. | 2004-11-12 | Traditional | PDF ↗ |
| K042617 | 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA | Siemens Medical Solutions USA, Inc. | 2004-11-05 | Traditional | PDF ↗ |
| K042844 | GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL | Ge Medical Systems, Inc. | 2004-11-03 | Special | PDF ↗ |
| K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL | Usa Instruments, Inc. | 2004-09-24 | Special | PDF ↗ |
| K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY | Usa Instruments, Inc. | 2004-08-26 | Special | PDF ↗ |
| K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K042103 | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL | Mri Devices Corporation | 2004-08-16 | Special | PDF ↗ |
| K042009 | MARK III PHASED ARRAY SHOULDER COIL | Usa Instruments, Inc. | 2004-08-11 | Special | PDF ↗ |
| K041921 | GE SIGNA PROFILE 6 INCH GP COIL | Ge Medical Systems, LLC | 2004-07-26 | Special | PDF ↗ |
| K041481 | MODEL BBC-127 BIOPSY BREAST COIL | Mri Devices Corp. | 2004-07-19 | Special | PDF ↗ |
| K041487 | QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT | Usa Instruments, Inc. | 2004-06-17 | Special | PDF ↗ |
| K041185 | TORSO ARRAY COIL, MODEL 558GE-64 | Igc-Medical Advances, Inc. | 2004-05-14 | Traditional | PDF ↗ |
| K041145 | MODIFICATION TO E-SCAN XQ MRI SYSTEM | Esaote, S.p.A. | 2004-05-14 | Special | PDF ↗ |
| K040937 | TEM 3000 HEAD COIL | Mr Instruments, Inc. | 2004-04-23 | Traditional | PDF ↗ |
| K040122 | MAYO CLINIC BC-10 3.0T | Mayo Clinic | 2004-04-14 | Special | PDF ↗ |
| K040640 | MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL | Igc-Medical Advances, Inc. | 2004-03-22 | Traditional | PDF ↗ |
| K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2004-03-09 | Special | PDF ↗ |
| K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL | Mri Devices Corp. | 2004-03-09 | Special | PDF ↗ |
| K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | Mri Devices Corp. | 2004-03-05 | Special | PDF ↗ |
| K033662 | SYNERGY SPINE ARRAY COIL | Philips Medical Systems, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K033490 | SPIRIT 5000 CARDIAC COIL | Usa Instruments, Inc. | 2004-01-09 | Traditional | PDF ↗ |
| K033753 | PELVIC ARRAY COIL | Usa Instruments, Inc. | 2003-12-17 | Special | PDF ↗ |
| K033235 | GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL | Usa Instruments, Inc. | 2003-12-17 | Traditional | PDF ↗ |
| K033292 | AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 | Igc-Medical Advances, Inc. | 2003-11-26 | Traditional | PDF ↗ |
| K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS | Mri Devices Corp. | 2003-11-25 | Special | PDF ↗ |
| K033353 | MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES | Usa Instruments, Inc. | 2003-11-14 | Special | PDF ↗ |
| K032576 | BIOPSY BREAST COIL, MODEL BBC | Mri Devices Corp. | 2003-10-23 | Special | PDF ↗ |
| K033152 | HAC-12 AND HAC-30 HEAD ARRAY COIL | Mri Devices Corp. | 2003-10-10 | Special | PDF ↗ |
| K033151 | KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL | Mri Devices Corp. | 2003-10-10 | Special | PDF ↗ |
| K032633 | HRK-63-8 KNEE ARRAY COIL | Mri Devices Corp. | 2003-09-25 | Special | PDF ↗ |
| K032618 | 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL | Usa Instruments, Inc. | 2003-09-12 | Special | PDF ↗ |
| K032538 | 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL | Usa Instruments, Inc. | 2003-09-12 | Special | PDF ↗ |
| K032474 | 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL | Usa Instruments, Inc. | 2003-08-25 | Special | PDF ↗ |
| K032415 | MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL | Usa Instruments, Inc. | 2003-08-25 | Special | PDF ↗ |
| K032429 | QSC-127 SHOULDER ARRAY COIL SET | Mri Devices Corp. | 2003-08-21 | Special | PDF ↗ |
| K032090 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 | Mri Devices Corp. | 2003-08-21 | Special | PDF ↗ |
| K032045 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | GE Medical Systems | 2003-07-30 | Special | PDF ↗ |
| K031536 | BRAIN COIL, MODEL 9900GE-64 | Clinical MR Solutions, LLC | 2003-07-18 | Traditional | PDF ↗ |
| K031365 | PRIMA III TOTALSENSE TORSO COIL | Usa Instruments, Inc. | 2003-07-18 | Traditional | PDF ↗ |
| K031119 | MAYO CLINIC BC-10 1.5T | Mayo Medical Ventures | 2003-07-15 | Abbreviated | PDF ↗ |
| K031366 | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-07-11 | Traditional | PDF ↗ |
| K031095 | SENSE BODY COIL | Philips Medical Systems (Cleveland), Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K031139 | PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-05-29 | Traditional | PDF ↗ |
| K031172 | SPIRIT III TOTALSENSE CARDIAC COIL | Usa Instruments, Inc. | 2003-05-29 | Traditional | PDF ↗ |
| K031143 | ALPHA 5000 WRIST COIL | Usa Instruments, Inc. | 2003-05-29 | Traditional | PDF ↗ |
| K031209 | GE 1.5T 8 CHANNEL TORSO COIL | Ge Medical Systems, Inc. | 2003-05-23 | Special | PDF ↗ |
| K031089 | GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY | W. L. Gore & Associates, Inc. | 2003-05-08 | Special | PDF ↗ |
| K031056 | MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL | Usa Instruments, Inc. | 2003-05-08 | Special | PDF ↗ |
| K030371 | PRIMA III TOTALSENSE TORSO COIL | Usa Instruments, Inc. | 2003-05-05 | Traditional | PDF ↗ |
| K030540 | HTS ARRAY COIL | Jockey Club Mri Engineering Center | 2003-04-16 | Traditional | PDF ↗ |
| K030953 | GE 3.0T GENERAL PURPOSE FLEX COIL | Ge Medical Systems, Inc. | 2003-04-10 | Special | PDF ↗ |
Product code MOS · Class II · Radiology. Data: openFDA.