Aquarius 8600 1417TG and Aquarius 8600 1717TG— 510(k) K171169

Name: FDA 510(k) clearance K171169
Creator: U.S. Food and Drug Administration
Published: 2017-10-12

Substantially Equivalent

Imaging Dynamics Company , Ltd.

FDA 510(k) clearance K171169 for Aquarius 8600 1417TG and Aquarius 8600 1717TG, Substantially Equivalent on 2017-10-12. Applicant: Imaging Dynamics Company , Ltd.. Device class: 2.

Clearance details

Applicant: Imaging Dynamics Company , Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-04-21
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

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