Medical Device Manufacturer · US , Pewaukee , WI

Neocoil, LLC - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2007

Recent clearances: 0.55T 12Ch Breast Coil, 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil, 32Ch 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 16ch

Official Website

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Neocoil, LLC Radiology ✕

17 devices

1-12 of 17

Cleared Apr 23, 2026

0.55T 12Ch Breast Coil

Radiology · 31d

Cleared Oct 14, 2022

16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast...

Radiology · 66d

Cleared Mar 11, 2022

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR...

Radiology · 108d

Cleared Jun 02, 2020

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil

Radiology · 39d

Cleared Nov 16, 2018

1.5T 16ch Breast Coil

Radiology · 23d

Cleared Feb 16, 2018

Wireless Audio System

Radiology · 107d

Cleared Nov 28, 2017

3.0T 16ch Breast Coil

Radiology · 29d

Cleared Jun 16, 2016

ECG CT Gating Device

Radiology · 129d

Cleared Jul 31, 2014

3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE

Radiology · 24d

Cleared Jul 24, 2014

HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE

Radiology · 237d

Cleared Dec 26, 2013

1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE

Radiology · 48d

Cleared Mar 28, 2013

1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM

Radiology · 160d