Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K041719 |
Device Name |
ONCENTRA-VISIR |
Applicant |
NUCLETRON CORP. |
8671 ROBERT FULTON DRIVE |
COLUMBIA,
MD
21046
|
|
Applicant Contact |
LISA DIMMICK |
Correspondent |
NUCLETRON CORP. |
8671 ROBERT FULTON DRIVE |
COLUMBIA,
MD
21046
|
|
Correspondent Contact |
LISA DIMMICK |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/24/2004 |
Decision Date | 07/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|