Cleared Abbreviated

ROTOGRAPH EVO 3D

K111152 · Villa Sistemi Medicali S.P.A. · Radiology
Jul 2011
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K111152 is an FDA 510(k) clearance for the ROTOGRAPH EVO 3D, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on July 22, 2011, 88 days after receiving the submission on April 25, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K111152 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2011
Decision Date July 22, 2011
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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