Ezra Flash— 510(k) K242334

Substantially Equivalent

Ezra Ai, Inc.

FDA 510(k) clearance K242334 for Ezra Flash, Substantially Equivalent on 2025-01-02. 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: 2024-08-07
Decision date: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ezra Ai, Inc.

K230264 — Ezra Flash2023-04-13
K192969 — Ezra Plexo Software2020-07-10

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