Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K152983 |
Device Name |
FUJIFILM SonoSite iViz Ultrasound System |
Applicant |
FUJIFILM SONOSITE,INC. |
21919 30th Dr SE |
BOTHELL,
WA
98021 -3904
|
|
Applicant Contact |
PATRICIA LIAU |
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 | 10/09/2015 |
Decision Date | 11/12/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|