Medsynapse Ris Pacs & Medsynapse VNA

System, Image Processing, Radiological

Medsynaptic Private Ltd

The following data is part of a premarket notification filed by Medsynaptic Private Ltd with the FDA for Medsynapse Ris Pacs & Medsynapse Vna.

Pre-market Notification Details

Device IDK192508
501k NumberK192508
Device Name:Medsynapse Ris Pacs & Medsynapse VNA
ClassificationSystem, Image Processing, Radiological
Applicant Medsynaptic Private Ltd 5th Floor, Mantri Galleria, Off S.B. Road Model Colony Shivaji Nagar,  IN 411016
ContactAshish Dhawad
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-12
Decision Date2019-11-22

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