Edge Air(1417) Digital Flat Panel X-ray Detector— 510(k) K201503

Name: FDA 510(k) clearance K201503
Creator: U.S. Food and Drug Administration
Published: 2020-06-29

Substantially Equivalent

Osko, Inc.

FDA 510(k) clearance K201503 for Edge Air(1417) Digital Flat Panel X-ray Detector, Substantially Equivalent on 2020-06-29. Applicant: Osko, Inc.. Device class: 2.

Clearance details

Applicant: Osko, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-06-05
Decision date: 2020-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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