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, X-Ray, Tomography, Computed
510(k) Number K260391
Device Name AVIEW Aorta Metrics
Applicant
Coreline Soft Co., Ltd.
12, Donggyo-Ro 19-Gil, Mapo-Gu
Seoul,  KR 04001
Applicant Contact Hyeyi Park
Correspondent
Coreline Soft Co., Ltd.
12, Donggyo-Ro 19-Gil, Mapo-Gu
Seoul,  KR 04001
Correspondent Contact Hyeyi Park
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/06/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-