AngioCloud Service

System, Image Processing, Radiological

AngioCloud, LLC

The following data is part of a premarket notification filed by Angiocloud, Llc with the FDA for Angiocloud Service.

Pre-market Notification Details

Device IDK211713
510k NumberK211713
Device Name:AngioCloud Service
ClassificationSystem, Image Processing, Radiological
Applicant AngioCloud, LLC 1 Glenlake Parkway, Suite 200 Atlanta,  GA  30328
ContactJames Lewis
CorrespondentBahram Parvinian
Lighthouse Regulatory Consulting Group, LLC 3 Harrowgate CT Potomac,  MD  20854
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-03
Decision Date2022-04-28

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