AcroDTI Visualizer

System, Image Processing, Radiological

AcroViz Inc.

The following data is part of a premarket notification filed by Acroviz Inc. with the FDA for Acrodti Visualizer.

Pre-market Notification Details

Device IDK201948
510k NumberK201948
Device Name:AcroDTI Visualizer
ClassificationSystem, Image Processing, Radiological
Applicant AcroViz Inc. Rm. 6. HF, No. 152, Sec. 1. Zhongxiao E. Rd., Zhongzhcng Dist, Taipei,  TW 10050
ContactYung-chin Hsu
CorrespondentYung-chin Hsu
AcroViz Inc. Rm. 6. HF, No. 152, Sec. 1. Zhongxiao E. Rd., Zhongzhcng Dist, Taipei,  TW 10050
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2020-09-09

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.