510(k) K201382— X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

Substantially Equivalent

De Gotzen S.R.L.

Clearance details

Applicant: De Gotzen S.R.L.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2020-05-26
Decision date: 2020-11-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Olgiate Olona, IT

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