Coil, Magnetic Resonance, Specialty
Regulation 892.1000
10510(k)s in 12 months (491 all time)
0recalls in 12 months (38 all time)
37recalls that name a 510(k)
Top companies in MOS
| Company | 510(k)s | Recalls |
|---|---|---|
| Usa Instruments, Inc. | 63 | 2 |
| Mri Devices Corp. | 65 | 0 |
| Quality Electrodynamics | 33 | 9 |
| Invivo | 21 | 2 |
| Hitachi Medical Systems America, Inc. | 18 | 3 |
| GE Medical Systems | 19 | 1 |
| Neocoil | 18 | 2 |
| Medical Advances, Inc. | 19 | 0 |
| Medrad, Inc. | 18 | 0 |
| Philips North America Llc | 0 | 16 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 2007 | K072935 | SPEEDER 1.5T WRIST ARRAY COIL Quality Electrodynamics | MOS |
| Oct 31, 2007 | K072909 | 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL Siemens AG Medical Solutions, DE | MOS |
| Oct 30, 2007 | K072931 | MC 3003G-32R HEAD COIL Mr Instruments, Inc. | MOS |
| Sep 5, 2007 | K071966 | 1.5T MRGFUS PELVIC COIL Insightec-Txsonics, Inc. | MOS |
| Jul 23, 2007 | K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL Shanghai Chenguang Medical Technologies Co, Ltd., CN | MOS |
| Jul 18, 2007 | K071882 | MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, Shanghai Chenguang Medical Technologies Co, Ltd., CN | MOS |
| Jul 9, 2007 | K071534 | CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS Confirma, Inc. | MOS |
| Jun 28, 2007 | K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL Neocoil | MOS |
| Jun 13, 2007 | K071179 | NORAS OR HEAD HOLDER Siemens Medical Solutions USA, Inc. | MOS |
| May 22, 2007 | K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL Neocoil | MOS |
| Apr 11, 2007 | K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL Neocoil | MOS |
| Mar 26, 2007 | K070629 | FLEX AND LOOP COIL SET 1.5 T Siemens Medical Solutions, DE | MOS |
| Dec 12, 2006 | K063513 | ECHELON MR-RCC-150 CARDIAC COIL Hitachi Medical Systems America, Inc. | MOS |
| Nov 30, 2006 | K063342 | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS Medrad, Inc. | MOS |
| Nov 17, 2006 | K063373 | FLEX LOOP COIL SET 3T Siemens AG, DE | MOS |
| Oct 13, 2006 | K062767 | CTL-63 AND CTL-128 SPINE ARRAY COILS Invivo Corporation | MOS |
| Oct 5, 2006 | K062556 | ECHELON SHOULDER COIL Hitachi Medical Systems America, Inc. | MOS |
| Aug 18, 2006 | K061950 | HHF1 ECHELON MULTI-PURPOSE COIL Hitachi Medical Systems America, Inc. | MOS |
| Jul 28, 2006 | K061952 | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 Invivo | MOS |
| Jul 28, 2006 | K061715 | MRGFUS GENERAL PURPOSE AND BREAST COIL Insightec Txsonics, Inc. | MOS |
| Jun 19, 2006 | K061281 | INSIGHT HEAD COIL Insight Neuroimaging Systems, LLC | MOS |
| May 25, 2006 | K061170 | 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 Resonance Innovations, LLC | MOS |
| May 5, 2006 | K060758 | OR HEAD COIL 1.5 T Siemens Medical Solutions USA, Inc. | MOS |
| Apr 14, 2006 | K060873 | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS Sentinelle Medical, Inc., CA | MOS |
| Mar 31, 2006 | K060689 | 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL Resonance Innovations, LLC | MOS |
| Mar 29, 2006 | K060547 | ACCESS BREAST COIL 4/SMS Confirma, Inc. | MOS |
| Mar 15, 2006 | K060401 | MEDRAD 3.0T ECOIL IMAGING SYSTEM Medrad, Inc. | MOS |
| Nov 17, 2005 | K053042 | MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE Medrad, Inc. | MOS |
| Nov 16, 2005 | K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS Invivo Corporation | MOS |
| Nov 9, 2005 | K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY Usa Instruments, Inc. | MOS |
| Nov 3, 2005 | K052704 | MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE Invivo Corp. | MOS |
| Nov 1, 2005 | K052827 | MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS Medrad, Inc. | MOS |
| Oct 12, 2005 | K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A Invivo Corp. | MOS |
| Oct 7, 2005 | K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL Usa Instruments, Inc. | MOS |
| Oct 7, 2005 | K052584 | 1.5T 12 CHANNEL BODY ARRAY Usa Instruments, Inc. | MOS |
| Oct 4, 2005 | K052585 | 3T HD BREAST ARRAY Usa Instruments, Inc. | MOS |
| Aug 24, 2005 | K052045 | ACCESS BREAST COIL Confirma, Inc. | MOS |
| Aug 19, 2005 | K052200 | TEM 3000 HEAD COIL Mr Instruments, Inc. | MOS |
| Aug 16, 2005 | K052077 | G-SCAN CERVICAL SPINE COIL Esaote, S.p.A. | MOS |
| Aug 2, 2005 | K051618 | SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 Midwest Rf, LLC | MOS |
| Jul 14, 2005 | K051763 | QD KNEE/FOOT COIL, MODEL MJQJ-147A Toshiba America Medical Systems, In.C | MOS |
| Jun 28, 2005 | K051512 | CAC-127-8 CARDOAC ARRAY COIL Invivo Corp. | MOS |
| Jun 28, 2005 | K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES Usa Instruments, Inc. | MOS |
| Jun 23, 2005 | K051349 | 3.0T PROSTATE IMAGING SYSTEM Medrad, Inc. | MOS |
| Apr 8, 2005 | K050622 | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL Mri Devices Corporation | MOS |
| Apr 7, 2005 | K050621 | NVA-127-8-A NEUROVASCULAR ARRAY COIL Mri Devices Corporation | MOS |
| Mar 25, 2005 | K050514 | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS Mri Devices Corporation | MOS |
| Mar 25, 2005 | K050476 | CORDLESS COIL Siemens Medical Solution, Inc. USA | MOS |
| Feb 28, 2005 | K050307 | AIRIS ELITE RAPID BODY COIL Hitachi Medical Systems America, Inc. | MOS |
| Feb 24, 2005 | K050299 | HRK-123 KNEE ARRAY COIL Mri Devices Corporation | MOS |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.