Automated Radiological Image Processing Software

AmCad BioMed Corporation

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

Pre-market Notification Details

Device IDK203555
510k NumberK203555
Device Name:AmCAD-UT
ClassificationAutomated Radiological Image Processing Software
Applicant AmCad BioMed Corporation FL. 5-2, No.167, Fu Hsing N. RD. Taipei,  TW 105
ContactNathan Liu
CorrespondentNathan Liu
AmCad BioMed Corporation FL.5-2, NO.167, Fu Hsing N. RD. Taipei 105,  TW
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-09-08

© 2021
This site is not affiliated with or endorsed by the FDA.