3D Echo V1.1

System, Image Processing, Radiological

JointVue LLC

The following data is part of a premarket notification filed by Jointvue Llc with the FDA for 3d Echo V1.1.

Pre-market Notification Details

Device IDK211656
510k NumberK211656
Device Name:3D Echo V1.1
ClassificationSystem, Image Processing, Radiological
Applicant JointVue LLC 2450 E.J. Chapman Drive, Suite 104A Knoxville,  TN  37996
ContactMaja Ward
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-05-28
Decision Date2021-06-25

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