DIAGNOSTICPRO EDGE

Digitizer, Image, Radiological

VIDAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Diagnosticpro Edge.

Pre-market Notification Details

Device IDK130406
510k NumberK130406
Device Name:DIAGNOSTICPRO EDGE
ClassificationDigitizer, Image, Radiological
Applicant VIDAR SYSTEMS CORP. 365 Herndon Pkwy Herndon,  VA  20170
ContactCarrie L Brancart
CorrespondentCarrie L Brancart
VIDAR SYSTEMS CORP. 365 Herndon Pkwy Herndon,  VA  20170
Product CodeLMA  
CFR Regulation Number892.2030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-19
Decision Date2013-04-29
Summary:summary

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