Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K060633 |
Device Name |
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. |
CONCORD,
CA
94520
|
|
Applicant Contact |
CHRISTINE DUNBAR |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
CHRISTINE DUNBAR |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/09/2006 |
Decision Date | 05/01/2006 |
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
|
|
|