Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K012289 |
Device Name |
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) |
Applicant |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
3155 NORTHWOODS PKWY. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
PETER STEGAGNO |
Correspondent |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
3155 NORTHWOODS PKWY. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
PETER STEGAGNO |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/20/2001 |
Decision Date | 08/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|