Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K220940 |
Device Name |
EchoPAC Software Only, EchoPAC Plug-in |
Applicant |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
LLC |
9900 W. Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Tracey Ortiz |
Correspondent |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
LLC |
9900 W. Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Lee Bush |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/31/2022 |
Decision Date | 07/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|