Visible Patient Suite

System, Image Processing, Radiological

Visible Patient, SAS

The following data is part of a premarket notification filed by Visible Patient, Sas with the FDA for Visible Patient Suite.

Pre-market Notification Details

Device IDK212896
510k NumberK212896
Device Name:Visible Patient Suite
ClassificationSystem, Image Processing, Radiological
Applicant Visible Patient, SAS 8 Rue Gustave Adolphe HIRN Strasbourg,  FR 67000
ContactEmeline Degivry
CorrespondentJohn J Smith
Hogan Lovells US LLP 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-10
Decision Date2021-11-05

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