ROTOGRAPH EVO 3D

System, X-ray, Extraoral Source, Digital

VILLA SISTEMI MEDICALI S.P.A.

The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Rotograph Evo 3d.

Pre-market Notification Details

Device IDK111152
510k NumberK111152
Device Name:ROTOGRAPH EVO 3D
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco,  IT 20090
ContactPaolo Casagrande Santin
CorrespondentPaolo Casagrande Santin
VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco,  IT 20090
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-25
Decision Date2011-07-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08052870661012 K111152 000

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