ClearanceBrief
Panels › Radiology › Product code MOS · Class 2

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)
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Top companies in MOS

DateFirm and productCodeLinked 510(k)
Nov 25, 2024Philips North America Llc
ST SENSE Breast Dx Coil
Open, Classified
MOSK093284
Nov 25, 2024Philips North America Llc
ST SENSE Breast Coil
Open, Classified
MOSK024208
Nov 25, 2024Philips North America Llc
SENSE Breast Coil 3.0T 7ch
Open, Classified
MOSK041481
Nov 25, 2024Philips North America Llc
SENSE Breast Coil
Open, Classified
MOSK022488
Nov 25, 2024Philips North America Llc
Mammotrak Interventional Coil 3.0T
Open, Classified
MOSNone listed
Nov 25, 2024Philips North America Llc
Mammotrak Diagnostic Coil 3.0T
Open, Classified
MOSK072873
Nov 25, 2024Philips North America Llc
Mammotrak Interventional Coil 1.5T
Open, Classified
MOSK032576
Nov 25, 2024Philips North America Llc
Mammotrak Diagnostic Coil 1.5T
Open, Classified
MOSK072873
Nov 25, 2024Philips North America Llc
dS Breast 7ch 3.0T
Open, Classified
MOSK032576
Nov 25, 2024Philips North America Llc
dS Breast 7ch 1.5T
Open, Classified
MOSK032576
Nov 25, 2024Philips North America Llc
dS Breast 16ch 3.0T
Open, Classified
MOSK072873
Nov 25, 2024Philips North America Llc
dS Breast 16ch 1.5T
Open, Classified
MOSK072873
Nov 25, 2024Philips North America Llc
Achieva TX Interventional Coil 3.0T
Open, Classified
MOSK032576
Jun 27, 2024Philips 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
MOSK043147
K052013
Jun 27, 2024Philips 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
MOSK043147
K052013
Jun 27, 2024Philips 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
MOSK043147
K052013
Sep 14, 2020Invivo 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
MOSK033567
K053017 +2
Aug 20, 2019Quality Electrodynamics LLC
TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
Terminated
MOSK082636
Aug 20, 2019Quality Electrodynamics LLC
TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
Terminated
MOSK082636
Aug 20, 2019Quality Electrodynamics LLC
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
Terminated
MOSK082636
Aug 20, 2019Quality Electrodynamics LLC
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Terminated
MOSK082636
Aug 20, 2019Quality Electrodynamics LLC
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Terminated
MOSK082636
Aug 20, 2019Quality Electrodynamics LLC
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Terminated
MOSK082636
Aug 20, 2019Quality Electrodynamics LLC
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Terminated
MOSK082636
Mar 19, 2019GE 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
MOSK172695
Jun 17, 2016NeoCoil, 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
MOSK141832
May 6, 2016Invivo Corporation
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Terminated
MOSK100113
Dec 28, 2015GE 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
MOSK110610
Dec 18, 2015NeoCoil, 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
MOSK103342
Aug 10, 2015Hitachi 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
MOSK072279
Sep 6, 2012Quality 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
MOSK082636
May 4, 2012GE 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
MOSK103335
Sep 22, 2010Philips 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
MOSK052013
May 19, 2010Hitachi Medical Systems America Inc
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
Terminated
MOSK001334
Sep 10, 2009Quality 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
MOSK083160
Nov 9, 2006USA Instruments Incorporated
3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.
Terminated
MOSK052916
Nov 9, 2006USA Instruments Incorporated
1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.
Terminated
MOSK052621
Nov 4, 2006Hitachi Medical Systems America Inc
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Terminated
MOSK052172

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