Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K183210 |
Device Name |
Thoracic VCAR with GSI Pulmonary Perfusion |
Applicant |
GE Medical Systems SCS |
283 rue de la Miniere |
Buc,
FR
78530
|
|
Applicant Contact |
Peter Uhlir |
Correspondent |
GE Medical Systems, LLC. |
3000 North Grandview Blvd |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Helen Peng |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/19/2018 |
Decision Date | 03/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|