Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K063085 |
Device Name |
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRD WAY |
P O BOX 7393 |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Applicant Contact |
SHEILA W PICKERING |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRD WAY |
P O BOX 7393 |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Correspondent Contact |
SHEILA W PICKERING |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/10/2006 |
Decision Date | 11/14/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|