Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K121663 |
Device Name |
CLARITY |
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 | 06/05/2012 |
Decision Date | 12/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|