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 Street, Centre Square 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
Recalls CDRH Recalls
-
-