Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K032996 |
Device Name |
ELEKTA SYNERGY SYSTEM |
Applicant |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
4775 PEACHTREE INDUSTRIAL BLVD |
BLDG 300, SUITE 300 |
NORCROSS,
GA
30092
|
|
Applicant Contact |
PETER STEGAGNO |
Correspondent |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
4775 PEACHTREE INDUSTRIAL BLVD |
BLDG 300, SUITE 300 |
NORCROSS,
GA
30092
|
|
Correspondent Contact |
PETER STEGAGNO |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 09/25/2003 |
Decision Date | 10/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|