Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-