Device Classification Name |
system, radiation therapy, charged-particle, medical
|
510(k) Number |
K091629 |
Device Name |
PROTEUS 235 PROTON THERAPY SYSTEM |
Applicant |
ION BEAM APPLICATIONS S.A. |
3 CHEMIN DU CYCLOTRON |
LOUVAIN-LA-NEUVE, BE,
BE
1348
|
|
Applicant Contact |
YVES JONGEN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/03/2009 |
Decision Date | 08/11/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|