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 K082416
Device Name IBA PROTON THERAPY SYSTEM- PROTEUS 235
Applicant
ION BEAM APPLICATIONS S.A.
1500 MARKET STREET
CENTRE SQUARE WEST, 38TH FLOOR
PHILADELPHIA,  PA  19102
Applicant Contact JOHN REISS
Correspondent
ION BEAM APPLICATIONS S.A.
1500 MARKET STREET
CENTRE SQUARE WEST, 38TH FLOOR
PHILADELPHIA,  PA  19102
Correspondent Contact JOHN REISS
Regulation Number892.5050
Classification Product Code
LHN  
Date Received08/21/2008
Decision Date 12/12/2008
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
-
-