SECURVIEW DX DIAGNOSTIC WORKSTATION

System, Image Processing, Radiological

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Securview Dx Diagnostic Workstation.

Pre-market Notification Details

Device IDK103385
510k NumberK103385
Device Name:SECURVIEW DX DIAGNOSTIC WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury,  CT  06810
ContactGail Yaeker-daunis
CorrespondentGail Yaeker-daunis
HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury,  CT  06810
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-18
Decision Date2011-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045504523 K103385 000

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