Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K111332 |
Device Name |
CLARITY OBP SYSTEM |
Applicant |
ELEKTA LTD. |
2050 BLEURY, SUITE 200 |
MONTREAL,
CA
H3A 2J5
|
|
Applicant Contact |
GEORGE PAPAGIANNIS |
Correspondent |
ELEKTA LTD. |
2050 BLEURY, SUITE 200 |
MONTREAL,
CA
H3A 2J5
|
|
Correspondent Contact |
GEORGE PAPAGIANNIS |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/11/2011 |
Decision Date | 01/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|