FDA · official record K133620Substantially Equivalent

CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM

Name: CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM — FDA K133620
Creator: Imaging Sciences International
Keywords: CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM, CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM, K133620, OAS, FDA

United StatesOASImaging Sciences International

Verified

Official record identity

FDA application number: K133620
Decision date: May 14, 2014
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: 2013-11-25
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.