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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K231855
Device Name QOCA® image Smart RT Contouring System
Applicant
Quanta Computer Inc.
No. 188, Wenhua 2nd Rd
Guishan Dist.
Taoyuan City,  TW 33383
Applicant Contact Joe Wang
Correspondent
Quanta Computer Inc.
No. 188, Wenhua 2nd Rd
Guishan Dist.
Taoyuan City,  TW 33383
Correspondent Contact Joe Wang
Regulation Number892.2050
Classification Product Code
QKB  
Date Received06/23/2023
Decision Date 02/13/2024
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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