FDA 510(k) Applications Submitted by Katie Gonzalez

FDA 510(k) Number Submission Date Device Name Applicant
K201101 04/24/2020 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil NeoCoil, LLC
K222407 08/09/2022 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 NeoCoil, LLC
K123272 10/19/2012 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM NEOCOIL, LLC
K182958 10/24/2018 1.5T 16ch Breast Coil NeoCoil, LLC
K133422 11/08/2013 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE NEOCOIL, LLC
K213687 11/23/2021 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 NeoCoil, LLC


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