X-MIND Prime (under Trade Mark Acteon), I-MAX (under Trade Mark Owandy Radiology)

System, X-ray, Extraoral Source, Digital

De Götzen S.r.l.

The following data is part of a premarket notification filed by De Götzen S.r.l. with the FDA for X-mind Prime (under Trade Mark Acteon), I-max (under Trade Mark Owandy Radiology).

Pre-market Notification Details

Device IDK203374
510k NumberK203374
Device Name:X-MIND Prime (under Trade Mark Acteon), I-MAX (under Trade Mark Owandy Radiology)
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant de Götzen S.r.l. Via Roma, 45 Olgiate Olona,  IT 21057
ContactDario Bandiera
CorrespondentDario Bandiera
de Götzen S.r.l. Via Roma, 45 Olgiate Olona,  IT 21057
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2021-02-05

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