AmCAD-UO

System, Image Processing, Radiological

AmCad BioMed Corporation

The following data is part of a premarket notification filed by Amcad Biomed Corporation with the FDA for Amcad-uo.

Pre-market Notification Details

Device IDK180867
510k NumberK180867
Device Name:AmCAD-UO
ClassificationSystem, Image Processing, Radiological
Applicant AmCad BioMed Corporation FL. 5-2, No. 167, Fu Hsing N. RD. Taipei,  TW 105
ContactJack Yang
CorrespondentChiu S. Lin
Lin & Associates, LLC 5614 Johnson Avenue Bethesda,  MD  20817
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-02
Decision Date2018-12-28
Summary:summary

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