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 K261655
Device Name RT Elements (4.6)
Applicant
Brainlab SE
Olof-Palme-Str.9
Munich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab SE
Olof-Palme-Str.9
Munich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
QIH  
Date Received05/19/2026
Decision Date 10/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-