Device Classification Name |
System, Radiation Therapy, Charged-Particle, Medical
|
510(k) Number |
K163500 |
Device Name |
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) |
Applicant |
Ion Beam Applications S.A. |
Chemin du Cyclotron, 3 |
Louvain-la-Neuve,
BE
1348
|
|
Applicant Contact |
Anne-Sophie Grell |
Correspondent |
SAUL EWING LLP |
1500 Market Street, Centre Square West-38th Floor |
PHILADELPHIA,
PA
19102
|
|
Correspondent Contact |
Bruce D Armon |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 12/13/2016 |
Decision Date | 08/17/2017 |
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
|
|
|