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 K260607
Device Name Shield System (Siemens 30x40)
Applicant
Radiaction , Ltd.
Hanechoshet 10
Floor 5
Tel Aviv,  IL 6971072
Applicant Contact Shlomit Cymbalista
Correspondent
Radiaction , Ltd.
Hanechoshet 10
Floor 5
Tel Aviv,  IL 6971072
Correspondent Contact Yossi Muncher
Regulation Number892.1650
Classification Product Code
OWB  
Date Received02/24/2026
Decision Date 07/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-