HCP DICOM NET

System, Image Processing, Radiological

SOFTLINK INTERNATIONAL INC.

The following data is part of a premarket notification filed by Softlink International Inc. with the FDA for Hcp Dicom Net.

Pre-market Notification Details

Device IDK023467
510k NumberK023467
Device Name:HCP DICOM NET
ClassificationSystem, Image Processing, Radiological
Applicant SOFTLINK INTERNATIONAL INC. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
SOFTLINK INTERNATIONAL INC. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-16
Decision Date2003-01-07
Summary:summary

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