Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K211726 |
Device Name |
Acuson SC2000 Diagnostic Ultrasound System |
Applicant |
Siemens Medical Solutions USA, Inc. |
685 East Middlefield Road |
Mountain View,
CA
94043
|
|
Applicant Contact |
Christine Dunbar |
Correspondent |
Siemens Medical Solutions USA, Inc. |
685 East Middlefield Road |
Mountain View,
CA
94043
|
|
Correspondent Contact |
Christine Dunbar |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/04/2021 |
Decision Date | 11/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|