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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 Triage And Notification Software
510(k) Number K182875
Device Name DeepCT
Applicant
Deep01 Limited
Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd.
Taipei City,  TW 10091
Applicant Contact William Lai
Correspondent
Deep01 Limited
Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd.
Taipei City,  TW 10091
Correspondent Contact William Lai
Regulation Number892.2080
Classification Product Code
QAS  
Date Received10/12/2018
Decision Date 07/10/2019
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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