Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K121657 |
Device Name |
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR |
Applicant |
PROTON SYSTEMS |
611 WEST 5TH STREET |
THIRD FLOOR |
AUSTIN,
TX
78701
|
|
Applicant Contact |
MIKE BEGALA |
Correspondent |
PROTON SYSTEMS |
611 WEST 5TH STREET |
THIRD FLOOR |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
MIKE BEGALA |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/05/2012 |
Decision Date | 10/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|