Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K122491 |
Device Name |
VIAMO SSA-640A V4.0 |
Applicant |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
CHARLEMAGNE CHUA |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/15/2012 |
Decision Date | 09/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|