SMART FINDER

System, X-ray, Mammographic

IMS Giotto S.p.A.

The following data is part of a premarket notification filed by Ims Giotto S.p.a. with the FDA for Smart Finder.

Pre-market Notification Details

Device IDK203509
510k NumberK203509
Device Name:SMART FINDER
ClassificationSystem, X-ray, Mammographic
Applicant IMS Giotto S.p.A. VIA Sagittario, 5 Sasso Marconi,  IT 40037
ContactAntonella Rossi
CorrespondentMarisa Testa
Thema S.r.l. Via Saragat, 5 Imola,  IT 40026
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2021-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056977360113 K203509 000

Trademark Results [SMART FINDER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMART FINDER
SMART FINDER
85372024 4317831 Dead/Cancelled
Worthwhile Products
2011-07-14

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