Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K112997 |
Device Name |
HD-IVUS ULTRASOUND IMAGING SYSTEM |
Applicant |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
47697 WESTINGHOUSE |
SUITE 101 |
FREMONT,
CA
94539
|
|
Applicant Contact |
RICHARD E ANDERSON |
Correspondent |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
47697 WESTINGHOUSE |
SUITE 101 |
FREMONT,
CA
94539
|
|
Correspondent Contact |
RICHARD E ANDERSON |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/07/2011 |
Decision Date | 12/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|