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, Radiation Therapy, Charged-Particle, Medical
510(k) Number K163500
Device Name IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
Applicant
Ion Beam Applications S.A.
Chemin Du Cyclotron, 3
Louvain-La-Neuve,  BE 1348
Applicant Contact Anne-Sophie Grell
Correspondent
Saul Ewing Llp
1500 Market St., Centre Sq. West-38th Floor
Philadelphia,  PA  19102
Correspondent Contact Bruce D Armon
Regulation Number892.5050
Classification Product Code
LHN  
Date Received12/13/2016
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-