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 System, Image Processing, Radiological
510(k) Number K200714
Device Name AVIEW
Applicant
Coreline Soft Co.,Ltd
4, 5f (Yeonnam-Dong) 49, World Cup Buk-Ro-6-Gil, Mapo-Gu
Seoul,  KR 03391
Applicant Contact Hyeyi Park
Correspondent
Coreline Soft Co.,Ltd
4, 5f (Yeonnam-Dong) 49, World Cup Buk-Ro-6-Gil, Mapo-Gu
Seoul,  KR 03391
Correspondent Contact Hyeyi Park
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received03/18/2020
Decision Date 08/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-