CSX-30 Flat Panel Detector— 510(k) K162909

Name: FDA 510(k) clearance K162909
Creator: U.S. Food and Drug Administration
Published: 2017-01-27

Substantially Equivalent

Canon, Inc. Medical Equipment Group

FDA 510(k) clearance K162909 for CSX-30 Flat Panel Detector, Substantially Equivalent on 2017-01-27. Applicant: Canon, Inc. Medical Equipment Group. Device class: 2.

Clearance details

Applicant: Canon, Inc. Medical Equipment Group
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2016-10-17
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kawasaki, JP

Download summary PDF View on FDA.gov ↗

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