Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K041484 |
Device Name |
UNDECIDED |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
RICHARD K ANDERSEN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
GLENN LUCHEN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/04/2004 |
Decision Date | 07/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|