NEOCOIL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063694843006369484NEOCOIL, LLC1N2026-01-01N27 W23910A PAUL RD. Pewaukee WI US 53072

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
0085002893249032ch AIR Open Coil Suite, 3.0T - The 32Ch AIR Open Coil Suite, 3.0T (NeoCoil Ref#: NC139020; GEHC Ref#: M7024RT) is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 3.0T field strengths:• AIR Open Head Neck Posterior 9ch• AIR Open Neck Chest Anterior 7ch• AIR Open Head Anterior 16chThe coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner).+1 (262) 522-6124kate.gonzalez@neocoil.com
0085002893250632ch AIR Open Coil Suite, 1.5T - The 32Ch AIR Open Coil Suite,1.5T (NeoCoil Ref#: NC139021; GEHC Ref#: M7025RT) is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T field strengths:• AIR Open Head Neck Posterior 9ch• AIR Open Neck Chest Anterior 7ch• AIR Open Head Anterior 16chThe coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner).+1 (262) 522-6124kate.gonzalez@neocoil.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
732811177526630K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast CoilMOS2022-10-14
732812027572987K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16chMOS2022-03-11
732811830206659K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilMOS2020-06-02
732811684715495K1829581.5T 16ch Breast CoilMOS2018-11-16
732811836136069K173409Wireless Audio SystemLNH2018-02-16
732811053801654K1733773.0T 16ch Breast CoilMOS2017-11-28
732811933064032K160350ECG CT Gating DeviceJAK2016-06-16
732811633258184K1418323T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGEMOS2014-07-31
732811435422858K133670HEADPHONES, PATIENT ALERT, STANDALONE INTERFACELNH2014-07-24
732811079302054K1334221.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGEMOS2013-12-26
732811480927796K1232721.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUMMOS2013-03-28
732811467798926K1213621.5T 16CH FLEX SPEEDER LARGEMOS2012-06-15
732811046181158K1134741.5T GEM FLEX COILMOS2012-03-16
732811204429097K1033423.0T METAFLEXCOILMOS2010-12-23
732811533361097K101632METAFLEXCOILMOS2010-08-24
732811117950521K073236NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GEMOS2007-11-30
732811799510351K071611NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COILMOS2007-06-28
732811262311258K071311NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COILMOS2007-05-22
732811708388260K070778NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COILMOS2007-04-11
732811236168887
732811962176774

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS162022-10-14
LNH22018-02-16
JAK12016-06-16

PMN#

GUDID#

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