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 |
|---|---|---|---|
| Apr 8, 2020 | K200477 | Flex Body Speeder Quality Electrodynamics, LLC | MOS |
| Jan 31, 2020 | K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support Rapid Biomedical GmbH, DE | MOS |
| Jan 3, 2020 | K193140 | Flex Body SPEEDER Quality Electrodynamics, LLC | MOS |
| Sep 9, 2019 | K190668 | Encompass 15 Channel Head Coil, 3T Qfix | MOS |
| Apr 12, 2019 | K182737 | 3T 32 Channel Head Coil Nova Medical, Inc. | MOS |
| Feb 8, 2019 | K183186 | Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Shanghai United Imaging Healthcare Co., Ltd., CN | MOS |
| Dec 7, 2018 | K183111 | Contour 24 Quality Electrodynamics, LLC | MOS |
| Nov 16, 2018 | K182958 | 1.5T 16ch Breast Coil Neocoil, LLC | MOS |
| Nov 16, 2018 | K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil Rapid Biomedical GmbH, DE | MOS |
| Oct 19, 2018 | K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA GE Healthcare | MOS |
| Oct 12, 2018 | K182504 | 3.0T Air MP M, 3.0T Air MP L Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Jul 11, 2018 | K181697 | 16ch Foot/ Ankle SPEEDER Quality Electrodynamics, LLC | MOS |
| Apr 12, 2018 | K180666 | 48CH Head Coil Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Mar 21, 2018 | K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil Rapid Biomedical GmbH, DE | MOS |
| Feb 16, 2018 | K180123 | Breast BI 7 MR Coil 1.5T Mammavention Noras Mri Products GmbH, DE | MOS |
| Jan 9, 2018 | K173469 | 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC | MOS |
| Dec 8, 2017 | K172222 | 8ch Flex Suite Shenzhen RF Tech Co., Ltd., CN | MOS |
| Nov 28, 2017 | K173377 | 3.0T 16ch Breast Coil Neocoil, LLC | MOS |
| Nov 28, 2017 | K173290 | DuoFLEX Coil Suite Mr Instruments, Inc. | MOS |
| Nov 22, 2017 | K172695 | AIR Anterior Array, AIR Posterior Array Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Nov 17, 2017 | K173446 | Contour 24 Quality Electrodynamics, LLC | MOS |
| Jul 26, 2017 | K171515 | NHAC 16 Lmt Medical Systems GmbH, DE | MOS |
| Jan 18, 2017 | K162651 | Breast BI 7 MR Coil Mammavention 3T Moras Mri Products GmbH, DE | MOS |
| Jan 12, 2017 | K163205 | 48CH Head Coil Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Jan 6, 2017 | K162946 | 8ch Knee-Foot SPEEDER Quality Electrodynamics, LLC | MOS |
| Dec 9, 2016 | K162623 | 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC | MOS |
| Nov 30, 2016 | K162966 | TxRx Knee 15 Flare MR Coil 1.5T Quality Electrodynamics, LLC | MOS |
| Nov 29, 2016 | K163066 | TxRx Knee 15 Flare MR Coil 3.0T Quality Electrodynamics, LLC | MOS |
| Nov 7, 2016 | K162863 | dS Small Extremity 16CH 1.5T Coil Invivo Therapeutics Corporation | MOS |
| Oct 18, 2016 | K162029 | 16ch T/R Knee Coil Quality Electrodynamics, LLC | MOS |
| Sep 16, 2016 | K162079 | TRILLIUM Oval Head Coil 32 Hitachi Medical Systems America, Inc. | MOS |
| Sep 14, 2016 | K162177 | dS FootAnkle I6CH 1.5T Coil Invivo Corporation | MOS |
| Aug 31, 2016 | K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils Invivo Corporation | MOS |
| Aug 1, 2016 | K160932 | 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd., CN | MOS |
| Jul 28, 2016 | K160935 | 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd., CN | MOS |
| Jun 2, 2016 | K161193 | 16ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC | MOS |
| Nov 18, 2015 | K152695 | 8 CH Knee SPEEDER Quality Electrodynamics, LLC | MOS |
| Aug 27, 2015 | K151753 | 16 ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC | MOS |
| Aug 7, 2015 | K151653 | 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd., CN | MOS |
| Jul 29, 2015 | K151829 | Atlas SPEEDER Header/Neck Quality Electrodynamics, LLC | MOS |
| Apr 9, 2015 | K150331 | 18ch T/R Knee Coil Quality Electrodynamics, LLC | MOS |
| Mar 6, 2015 | K143389 | 3.0T GEM RT Open Array Ge Healthcare Coils (Usa Instruments, Inc.) | MOS |
| Dec 5, 2014 | K142676 | Siemens 3.0T PROCURE Array Coil Resonance Innovations, LLC | MOS |
| Nov 24, 2014 | K142802 | Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC | MOS |
| Oct 23, 2014 | K142755 | Siemens 3.0 Blanket Array Coil Resonance Innovations, LLC | MOS |
| Aug 22, 2014 | K142002 | BREAST SPEEDER CX, GRID HOLDER CX Quality Electrodynamics, LLC | MOS |
| Aug 6, 2014 | K133506 | NORAS OR HEAD HOLDER FLEXIBILITY Noras Mri Products GmbH, DE | MOS |
| Jul 31, 2014 | K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE Neocoil, LLC | MOS |
| Jul 11, 2014 | K140998 | PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL Quality Electrodynamics, LLC | MOS |
| May 12, 2014 | K140606 | 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL Resonance Innovations, LLC | MOS |
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