• 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 x-ray angiographic imaging based coronary vascular simulation software device
510(k) Number K210093
Device Name AccuFFRangio
Applicant
ArteryFlow Technology Co., Ltd.
459 Qianmo Road, Suite C1-501, Binjiang District
Hangzhou,  CN 310051
Applicant Contact Jianping Xiang
Correspondent
ArteryFlow Technology Co., Ltd.
459 Qianmo Road, Suite C1-501, Binjiang District
Hangzhou,  CN 310051
Correspondent Contact Ashley Fu
Regulation Number892.1600
Classification Product Code
QHA  
Subsequent Product Code
LLZ  
Date Received01/14/2021
Decision Date 09/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-