DATACOM DC PACS

System, Image Processing, Radiological

DATACOM TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Datacom Technology Corp. with the FDA for Datacom Dc Pacs.

Pre-market Notification Details

Device IDK083182
510k NumberK083182
Device Name:DATACOM DC PACS
ClassificationSystem, Image Processing, Radiological
Applicant DATACOM TECHNOLOGY CORP. NO.58, FU CHIUN STREET Hsin Chu City Tw-hsq Taiwan,  CN 30067
ContactJen Ke-min
CorrespondentJen Ke-min
DATACOM TECHNOLOGY CORP. NO.58, FU CHIUN STREET Hsin Chu City Tw-hsq Taiwan,  CN 30067
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-28
Decision Date2009-03-04
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.