MICRODOSE SI

Full Field Digital, System, X-ray, Mammographic

PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB

The following data is part of a premarket notification filed by Philips Digital Mammography Sweden Ab with the FDA for Microdose Si.

Pre-market Notification Details

Device IDK123995
510k NumberK123995
Device Name:MICRODOSE SI
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5 Solna,  SE Se-171 41
ContactGustav Lins
CorrespondentGustav Lins
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5 Solna,  SE Se-171 41
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-26
Decision Date2013-02-01
Summary:summary

Trademark Results [MICRODOSE SI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MICRODOSE SI
MICRODOSE SI
79131247 4661406 Live/Registered
Koninklijke Philips N.V.
2013-04-18

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