Ezra Plexo Software— 510(k) K192969

Substantially Equivalent

Ezra Ai, Inc.

FDA 510(k) clearance K192969 for Ezra Plexo Software, Substantially Equivalent on 2020-07-10. Applicant: Ezra Ai, Inc.. Device class: 2.

Clearance details

Applicant: Ezra Ai, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-10-23
Decision date: 2020-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.