Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K150193 |
Device Name |
Customer Remote Console (CRC) |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3200 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
John W. Jaeckle |
Correspondent |
GE HEALTHCARE |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Elizabeth Mathew |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/28/2015 |
Decision Date | 03/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|