Bonelogic

System, Image Processing, Radiological

Disior Ltd

The following data is part of a premarket notification filed by Disior Ltd with the FDA for Bonelogic.

Pre-market Notification Details

Device IDK203290
510k NumberK203290
Device Name:Bonelogic
ClassificationSystem, Image Processing, Radiological
Applicant Disior Ltd Lapinlahdenkatu 16 Helsinki,  FI 00180
ContactMarkku Laitinen
CorrespondentMarkku Laitinen
Disior Ltd Lapinlahdenkatu 16 Helsinki,  FI 00180
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-09
Decision Date2021-02-05

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