Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K161588 |
Device Name |
Vscan Extend |
Applicant |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
9900 W. INNOVATION DRIVE |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
Tracey Ortiz |
Correspondent |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
9900 W. INNOVATION DRIVE |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
Tracey Ortiz |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/08/2016 |
Decision Date | 08/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|