Device Classification Name |
system, radiation therapy, charged-particle, medical
|
510(k) Number |
K060695 |
Device Name |
IBA PROTON THERAPY SYSTEM - PROTEUS 235 |
Applicant |
ION BEAM APPLICATIONS S.A. |
CENTRE SQUARE WEST |
1500 MARKET STREET, 38TH FLOOR |
PHILADELPHIA,
PA
19102 -2186
|
|
Applicant Contact |
JOHN B REISS |
Correspondent |
ION BEAM APPLICATIONS S.A. |
CENTRE SQUARE WEST |
1500 MARKET STREET, 38TH FLOOR |
PHILADELPHIA,
PA
19102 -2186
|
|
Correspondent Contact |
JOHN B REISS |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/16/2006 |
Decision Date | 04/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|