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 K262449
Device Name AdvaView
Applicant
ADVAHEALTH SOLUTIONS, LLC
8 The Green
#22208
Dover,  DE  19901
Applicant Contact Imad Nijim
Correspondent
Innolitics,, LLC
1101 W. 34th St.
#550
Austin,  TX  78705
Correspondent Contact Meritxell Martinez
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/16/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-