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— 510(k) K213687

Name: FDA 510(k) clearance K213687
Creator: U.S. Food and Drug Administration
Published: 2022-03-11

Substantially Equivalent

Neocoil, LLC

FDA 510(k) clearance K213687 for 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, Substantially Equivalent on 2022-03-11. Applicant: Neocoil, LLC. Device class: 2.

Clearance details

Applicant: Neocoil, LLC
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2021-11-23
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pewaukee, WI, US

Download summary PDF View on FDA.gov ↗

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