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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K221868
Device Name QOCA image Smart CXR Image Processing System
Applicant
Quanta Computer, Inc.
# 188, Wenhua 2nd Rd.
Guishan Dist.
Taoyuan City,  TW 33383
Applicant Contact Joe Wang
Correspondent
Quanta Computer, Inc.
# 188, Wenhua 2nd Rd.
Guishan Dist.
Taoyuan City,  TW 33383
Correspondent Contact Joe Wang
Regulation Number892.2080
Classification Product Code
QFM  
Date Received06/27/2022
Decision Date 01/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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