FDA · official record K181576Substantially Equivalent

Planmeca Viso

Name: Planmeca Viso — FDA K181576
Creator: Planmeca Oy
Keywords: Planmeca Viso, Planmeca Viso, K181576, OAS, FDA

United StatesOASPlanmeca Oy

Verified

Official record identity

FDA application number: K181576
Decision date: September 13, 2018
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Planmeca Oy

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2018-06-15
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.