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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2024 | Philips North America Llc ST SENSE Breast Dx Coil Open, Classified |
MOS | K093284 |
| Nov 25, 2024 | Philips North America Llc ST SENSE Breast Coil Open, Classified |
MOS | K024208 |
| Nov 25, 2024 | Philips North America Llc SENSE Breast Coil 3.0T 7ch Open, Classified |
MOS | K041481 |
| Nov 25, 2024 | Philips North America Llc SENSE Breast Coil Open, Classified |
MOS | K022488 |
| Nov 25, 2024 | Philips North America Llc Mammotrak Interventional Coil 3.0T Open, Classified |
MOS | None listed |
| Nov 25, 2024 | Philips North America Llc Mammotrak Diagnostic Coil 3.0T Open, Classified |
MOS | K072873 |
| Nov 25, 2024 | Philips North America Llc Mammotrak Interventional Coil 1.5T Open, Classified |
MOS | K032576 |
| Nov 25, 2024 | Philips North America Llc Mammotrak Diagnostic Coil 1.5T Open, Classified |
MOS | K072873 |
| Nov 25, 2024 | Philips North America Llc dS Breast 7ch 3.0T Open, Classified |
MOS | K032576 |
| Nov 25, 2024 | Philips North America Llc dS Breast 7ch 1.5T Open, Classified |
MOS | K032576 |
| Nov 25, 2024 | Philips North America Llc dS Breast 16ch 3.0T Open, Classified |
MOS | K072873 |
| Nov 25, 2024 | Philips North America Llc dS Breast 16ch 1.5T Open, Classified |
MOS | K072873 |
| Nov 25, 2024 | Philips North America Llc Achieva TX Interventional Coil 3.0T Open, Classified |
MOS | K032576 |
| Jun 27, 2024 | Philips North America Llc SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 45356750228 Open, Classified |
MOS | K043147 K052013 |
| Jun 27, 2024 | Philips North America Llc SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 45 Open, Classified |
MOS | K043147 K052013 |
| Jun 27, 2024 | Philips North America Llc SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits Open, Classified |
MOS | K043147 K052013 |
| Sep 14, 2020 | Invivo Corporation MR Coils
The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. Terminated |
MOS | K033567 K053017 +2 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx Knee 15 Coil 1.5T
QED part number: Q7000057
Siemens Model # 10606829 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx Knee 15 Coil 1.5T
QED part number: Q7000056
Siemens Model # 10606828 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 3T
QED part number: Q7000051
Siemens Model # 10606525 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 1.5T
QED part number: Q7000050
Siemens Model # 10606524 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx CP Extremity Coil 3T
QED part number: Q7000019
Siemens Model # 10185464 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15CH Knee Coil 1.5T
QED part number:Q7000016
Siemens Model # 10185453 Terminated |
MOS | K082636 |
| Aug 20, 2019 | Quality Electrodynamics LLC TxRx 15Ch Knee Coil 3T
QED part number:Q7000008
Siemens Model # 10185460 Terminated |
MOS | K082636 |
| Mar 19, 2019 | GE Healthcare, LLC AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems. Terminated |
MOS | K172695 |
| Jun 17, 2016 | NeoCoil, LLC 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the Terminated |
MOS | K141832 |
| May 6, 2016 | Invivo Corporation Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. Terminated |
MOS | K100113 |
| Dec 28, 2015 | GE Medical Systems, LLC GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS.
Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0 Terminated |
MOS | K110610 |
| Dec 18, 2015 | NeoCoil, LLC NeoCoil 3.0T GEM Flex Coil.
The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box.
3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 543 Terminated |
MOS | K103342 |
| Aug 10, 2015 | Hitachi Medical Systems America Inc Oasis Coil Extension Cable used with Hitachi Oasis MRI System
Product Usage:
The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical informat Terminated |
MOS | K072279 |
| Sep 6, 2012 | Quality Electrodynamics LLC TxRx Knee 15 Coil 3T.
For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. Terminated |
MOS | K082636 |
| May 4, 2012 | GE Healthcare, LLC GE Healthcare, Optima MR450W with GEM.
Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Health Terminated |
MOS | K103335 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x. Terminated |
MOS | K052013 |
| May 19, 2010 | Hitachi Medical Systems America Inc Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO Terminated |
MOS | K001334 |
| Sep 10, 2009 | Quality Electrodynamics Llc Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143.
The indications for use are routine MR imag Terminated |
MOS | K083160 |
| Nov 9, 2006 | USA Instruments Incorporated 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System. Terminated |
MOS | K052916 |
| Nov 9, 2006 | USA Instruments Incorporated 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System. Terminated |
MOS | K052621 |
| Nov 4, 2006 | Hitachi Medical Systems America Inc Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150. Terminated |
MOS | K052172 |
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