Planmed Clarity 2D And Clarity S

Full Field Digital, System, X-ray, Mammographic

Planmed Oy

The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Clarity 2d And Clarity S.

Pre-market Notification Details

Device IDK192317
510k NumberK192317
Device Name:Planmed Clarity 2D And Clarity S
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant Planmed Oy Sorvaajankatu 7 Helsinki,  FI 00880
ContactLars Moring
CorrespondentLars Moring
Planmed Oy Sorvaajankatu 7 Helsinki,  FI 00880
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-26
Decision Date2020-10-23

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.