i-CAT FLX V series / KaVo 3D eXam+ V series— 510(k) K162085

Name: FDA 510(k) clearance K162085
Creator: U.S. Food and Drug Administration
Published: 2016-11-10

Substantially Equivalent

Imaging Sciences International

FDA 510(k) clearance K162085 for i-CAT FLX V series / KaVo 3D eXam+ V series, Substantially Equivalent on 2016-11-10. Applicant: Imaging Sciences International. Device class: 2.

Clearance details

Applicant: Imaging Sciences International
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2016-07-27
Decision date: 2016-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, PA, US

Download summary PDF View on FDA.gov ↗

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