FDA 510(k) Applications Submitted by ION BEAM APPLICATIONS S.A.

FDA 510(k) Number Submission Date Device Name Applicant
K163500 12/13/2016 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A.
K132847 09/11/2013 I2C ION BEAM APPLICATIONS S.A.
K132919 09/17/2013 GANTRY BEAM LINE ION BEAM APPLICATIONS S.A.
K061913 07/06/2006 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A.
K082416 08/21/2008 IBA PROTON THERAPY SYSTEM- PROTEUS 235 ION BEAM APPLICATIONS S.A.
K060695 03/16/2006 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A.
K100766 03/17/2010 IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 ION BEAM APPLICATIONS S.A.
K101508 06/01/2010 MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 ION BEAM APPLICATIONS S.A.
K983024 08/31/1998 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A.
K092796 09/11/2009 IBA PROTON THERAPY SYSTEM, PROTEUS 235 ION BEAM APPLICATIONS S.A.
K083058 10/14/2008 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A.
K053641 12/30/2005 IBA PROTON THERAPY SYSTEM-PROTEUS 235 ION BEAM APPLICATIONS S.A.
K091629 06/03/2009 PROTEUS 235 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A.


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