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

Name: FDA 510(k) clearance K180601
Creator: U.S. Food and Drug Administration
Published: 2018-11-02

Substantially Equivalent

Villa Sistemi Medicali S.P.A.

FDA 510(k) clearance K180601 for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology), Substantially Equivalent on 2018-11-02. Applicant: Villa Sistemi Medicali S.P.A.. Device class: 2.

Clearance details

Applicant: Villa Sistemi Medicali S.P.A.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2018-03-07
Decision date: 2018-11-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buccinasco, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.