Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K163020 |
Device Name |
Xperius Ultrasound System |
Applicant |
PHILIPS HEALTHCARE |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98021 -8431
|
|
Applicant Contact |
SCOTT ZHANG |
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 | 10/31/2016 |
Decision Date | 11/16/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|