DIGITAL RADIOGRAPHY— 510(k) K112309

Name: FDA 510(k) clearance K112309
Creator: U.S. Food and Drug Administration
Published: 2011-09-02

Substantially Equivalent

Canon Inc. -Medical Equipment Group

FDA 510(k) clearance K112309 for DIGITAL RADIOGRAPHY, Substantially Equivalent on 2011-09-02. 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: 2011-08-11
Decision date: 2011-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Tachikawa-Shi, Tokyo, JP

Download summary PDF View on FDA.gov ↗

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