Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006369484

FEI Number

3006369484

Entity Name

NEOCOIL, LLC

City/State/Country

Pewaukee, WI, US

Establishment Address

N27 W23910A PAUL RD., Pewaukee, WI 53072, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NeoCoil, LLC (Owner Number: 9099325)

Owner / Operator Contact Address

N27 W23910A PAUL RD., Suite A, Pewaukee, WI 53072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133422

PMA Number

N/A

All Registered Proprietary Names

3T GE 6-Channel Phased Array Flex Coil 1.5T GE 6-Channel Phased Array Flex Coil 16ch Breast Coils 3T 16ch Breast Coil 1.5T 16ch Breast Coil GE 1.5T 6-Channel Phased Array Wireless Audio System NeoCoil 1.5T GEM Flex Coil 3T 32ch AIR Open Coil Suite 1.5T AIR Open Head Neck Posterior 9ch 3T AIR Open Head Neck Posterior 9ch 1.5T 32ch AIR Open Coil Suite 3T AIR Open Neck Chest Anterior 7ch 3T AIR Open Head Anterior 16ch 1.5T AIR Open Head Anterior 16ch 32Ch AIR Open Coil Suite 1.5T AIR Open Neck Chest Anterior 7ch NEOCOIL 3T 6-CHANN NEOCOIL 3T 6-Ch Carotid Coil 3T 16ch Breast Coil NEOCOIL 3T 8-Ch Shoulder Coil 1.5T Flex SPEEDER 3T Flex SPEEDER 3T 16ch Shoulder Coil 1.5T 16ch Shoulder Coil 1.5T Shoulder Coil HD 8ch Shoulder Coil NeoCoil 1.5T 8-Channel Shoulder Array Coil NeoCoil 1.5T 8-ch Shoulder Coil NEOCOIL 1.5T 8-Ch Shoulder Coil GEM Flex MetaFlex Coil GEM Flex Coil, 1.5T GEM Flex Coil 16-M Array, 1.5T Receive Only GEM Flex Interface 16ch Fixed, 1.5T P Connector GEM Flex Coil 16-L Array, 1.5T Receive Only GEM Flex Interface 16ch Fixed, 1.5T HD Connector GEM Flex Coil 16-S Array, 1.5T Receive Only 1.5T GEM Flex Coil Patient Entertainment and Communication System Sentinel, Patient Entertainment and Communication System 1.5T Flex Coil for Siemens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-06-20
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-11-02
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2009-12-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-03-13
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2011-08-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-08-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2007-07-02
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-03-13
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2009-12-18
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-10-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-10-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-07-13
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2007-11-13
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-05-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-10-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2014-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeoCoil, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006369484. Last updated year: 2026. Please use registration number 3006369484 when referencing this establishment in official correspondence.