FDA · official record K162085Substantially Equivalent

i-CAT FLX V series / KaVo 3D eXam+ V series

Name: i-CAT FLX V series / KaVo 3D eXam+ V series — FDA K162085
Creator: Imaging Sciences International
Keywords: i-CAT FLX V series / KaVo 3D eXam+ V series, i-CAT FLX V series / KaVo 3D eXam+ V series, K162085, OAS, FDA

United StatesOASImaging Sciences International

Verified

Official record identity

FDA application number: K162085
Decision date: November 10, 2016
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Imaging Sciences International

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2016-07-27
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.