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, Planning, Radiation Therapy Treatment
510(k) Number K220783
Device Name syngo.via RT Image Suite
Applicant
Siemens Medical Solutions USA Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Clayton Ginn
Correspondent
Siemens Medical Solutions USA Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Clayton Ginn
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/17/2022
Decision Date 09/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-