Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K061097 |
Device Name |
COHERENCE DOSIMETRIST, MODEL 2.2 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. |
CONCORD,
CA
94520
|
|
Applicant Contact |
KEN NEHMER |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
KEN NEHMER |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 04/19/2006 |
Decision Date | 06/07/2006 |
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
|
|
|