Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K163120 |
Device Name |
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System |
Applicant |
Philips Ultrasound, Inc. |
3000 Minuteman Road |
Andover,
MA
01810
|
|
Applicant Contact |
Peng Cui |
Correspondent |
Philips Ultrasound, Inc. |
3000 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Peng Cui |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/08/2016 |
Decision Date | 01/10/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|