Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K232145 |
Device Name |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System |
Applicant |
Siemens Medical Solutions USA, Inc. |
22010 South East 51st Street |
Issaquah,
WA
98029
|
|
Applicant Contact |
Sulgue Choi |
Correspondent |
Siemens Medical Solutions USA, Inc. |
22010 South East 51st Street |
Issaquah,
WA
98029
|
|
Correspondent Contact |
Sulgue Choi |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/19/2023 |
Decision Date | 10/30/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|