FDA · official record K201382Substantially Equivalent

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

Name: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) — FDA K201382
Creator: De Gotzen S.R.L.
Keywords: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology), X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology), K201382, OAS, FDA

United StatesOASDe Gotzen S.R.L.

Verified

Official record identity

FDA application number: K201382
Decision date: November 18, 2020
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: De Gotzen S.R.L.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2020-05-26
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.