Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K060912 |
Device Name |
MODIFICATION TO: HI-ART SYSTEM |
Applicant |
TOMOTHERAPY INCORPORATED |
1240 DEMING WAY |
MADISON,
WI
53717
|
|
Applicant Contact |
KENNETH D BUROKER |
Correspondent |
TOMOTHERAPY INCORPORATED |
1240 DEMING WAY |
MADISON,
WI
53717
|
|
Correspondent Contact |
KENNETH D BUROKER |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/03/2006 |
Decision Date | 04/19/2006 |
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
|
|
|