Ambra ProViewer

System, Image Processing, Radiological

Dicom Grid, Inc, Dba Ambra Health

The following data is part of a premarket notification filed by Dicom Grid, Inc, Dba Ambra Health with the FDA for Ambra Proviewer.

Pre-market Notification Details

Device IDK202335
510k NumberK202335
Device Name:Ambra ProViewer
ClassificationSystem, Image Processing, Radiological
Applicant Dicom Grid, Inc, Dba Ambra Health 199 Water St., 34th Floor New York,  NY  10038
ContactPatrice Nedelec
CorrespondentRafael Aguila
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum,  FL  33155
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-17
Decision Date2020-09-04

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