NeoCoil, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
20
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2312-2016Class II3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-2June 17, 2016
Z-1027-2016Class IINeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and December 18, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch BreastOctober 14, 2022
K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior March 11, 2022
K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilJune 2, 2020
K1829581.5T 16ch Breast CoilNovember 16, 2018
K173409Wireless Audio SystemFebruary 16, 2018
K1733773.0T 16ch Breast CoilNovember 28, 2017
K160350ECG CT Gating DeviceJune 16, 2016
K1418323T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGEJuly 31, 2014
K133670HEADPHONES, PATIENT ALERT, STANDALONE INTERFACEJuly 24, 2014
K1334221.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGEDecember 26, 2013
K1232721.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUMMarch 28, 2013
K1213621.5T 16CH FLEX SPEEDER LARGEJune 15, 2012
K1134741.5T GEM FLEX COILMarch 16, 2012
K1033423.0T METAFLEXCOILDecember 23, 2010
K101632METAFLEXCOILAugust 24, 2010
K073236NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GENovember 30, 2007
K073181NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COILNovember 21, 2007
K071611NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COILJune 28, 2007
K071311NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COILMay 22, 2007
K070778NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COILApril 11, 2007