Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K103144 |
Device Name |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER |
Applicant |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
7263 CRONIN CIRCLE |
DUBLIN,
CA
94568
|
|
Applicant Contact |
BOB LEIKER |
Correspondent |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
7263 CRONIN CIRCLE |
DUBLIN,
CA
94568
|
|
Correspondent Contact |
BOB LEIKER |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/25/2010 |
Decision Date | 01/12/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|