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 interventional fluoroscopic x-ray system
510(k) Number K210900
Device Name Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Applicant
Canon Medical Systems Corporation
1385 Shimoshigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems USA, INC.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Janine Reyes
Regulation Number892.1650
Classification Product Code
OWB  
Date Received03/26/2021
Decision Date 04/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-