Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K173962 |
Device Name |
Viamo c100 TUS-VC100 Diagnostic Ultrasound System |
Applicant |
Toshiba Medical Systems Corporation |
1385 Shimoishigami |
Otawara-Shi,
JP
324-8550
|
|
Applicant Contact |
Paul Biggins |
Correspondent |
Toshiba America Medical Systems, In.c |
2441 Michelle Drive |
Tustin,
CA
92780
|
|
Correspondent Contact |
Orlando Tadeo |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/28/2017 |
Decision Date | 04/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|