K180601

Substantially Equivalent

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

Applicant
Villa Sistemi Medicali S.P.A.
Product code
OAS
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Buccinasco, IT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.