Device Classification Name |
System, Radiation Therapy, Charged-Particle, Medical
|
510(k) Number |
K120676 |
Device Name |
S-250 PROTON BEAM RADIATION THERAPY SYSTEM |
Applicant |
MEVION MEDICAL SYSTEMS |
300 FOSTER ST |
LITTLETON,
MA
01460
|
|
Applicant Contact |
THOMAS H FARIS |
Correspondent |
MEVION MEDICAL SYSTEMS |
300 FOSTER ST |
LITTLETON,
MA
01460
|
|
Correspondent Contact |
THOMAS H FARIS |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/05/2012 |
Decision Date | 06/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|