FDA · official record K213579Substantially Equivalent

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Name: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph — FDA K213579
Creator: Fona S.R.L
Keywords: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph, Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph, K213579, OAS, FDA

United StatesOASFona S.R.L

Verified

Official record identity

FDA application number: K213579
Decision date: March 02, 2022
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Fona S.R.L

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-11-10
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.