Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K080929 |
Device Name |
ONCENTRA GYN |
Applicant |
NUCLETRON CORPORATION |
8671 ROBERT FULTON DR. |
COLUMBIA,
MD
21046 -2133
|
|
Applicant Contact |
LISA DIMMICK |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY Y KOGOMA |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 04/01/2008 |
Decision Date | 04/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|