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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K201948
Device Name AcroDTI Visualizer
Applicant
AcroViz Inc.
Rm. 6. HF, No. 152, Sec. 1. Zhongxiao E. Rd.,
Zhongzhcng Dist,
Taipei,  TW 10050
Applicant Contact Yung-Chin Hsu
Correspondent
AcroViz Inc.
Rm. 6. HF, No. 152, Sec. 1. Zhongxiao E. Rd.,
Zhongzhcng Dist,
Taipei,  TW 10050
Correspondent Contact Yung-Chin Hsu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/13/2020
Decision Date 09/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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