Accuvue+— 510(k) K201058

Substantially Equivalent

Radmedix, LLC

FDA 510(k) clearance K201058 for Accuvue+, Substantially Equivalent on 2020-05-06. Applicant: Radmedix, LLC. Device class: 2.

Clearance details

Applicant: Radmedix, LLC
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-04-21
Decision date: 2020-05-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.