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— 510(k) K222407

Name: FDA 510(k) clearance K222407
Creator: U.S. Food and Drug Administration
Published: 2022-10-14

Substantially Equivalent

Neocoil, LLC

FDA 510(k) clearance K222407 for 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, Substantially Equivalent on 2022-10-14. 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: 2022-08-09
Decision date: 2022-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Pewaukee, WI, US

Download summary PDF View on FDA.gov ↗

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K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil2020-06-02
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Data sourced from openFDA. This site is unofficial and independent of the FDA.