Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K142395 |
Device Name |
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
685 East Middlefield Road |
Mountain View,
CA
94043
|
|
Applicant Contact |
Shelly Pearce |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/27/2014 |
Decision Date | 09/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|