Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K192242 |
Device Name |
Synergy Platform, Synergy, Infinity, VersaHD |
Applicant |
Elekta Limited |
Linac House |
Fleming Way |
Crawley,
GB
rh10 9rr
|
|
Applicant Contact |
Irina Proutski |
Correspondent |
Elekta Limited |
Linac House |
Fleming Way |
Crawley,
GB
rh10 9rr
|
|
Correspondent Contact |
Irina Proutski |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 08/19/2019 |
Decision Date | 11/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|