Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K982713 |
Device Name |
RT DESKTOP |
Applicant |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
8 EXECUTIVE PARK WEST |
SUITE 809 |
ATLANTA,
GA
30329
|
|
Applicant Contact |
PAUL L SUMNER |
Correspondent |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
8 EXECUTIVE PARK WEST |
SUITE 809 |
ATLANTA,
GA
30329
|
|
Correspondent Contact |
PAUL L SUMNER |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 08/04/1998 |
Decision Date | 11/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|