510(k) K180601— Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

Substantially Equivalent

Villa Sistemi Medicali S.P.A.

Clearance details

Applicant: Villa Sistemi Medicali S.P.A.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2018-03-07
Decision date: 2018-11-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buccinasco, IT

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