Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K163213 |
Device Name |
Revolution CT |
Applicant |
GE Medical Systems, L.L.C. |
3000 N Grandview Blvd |
Waukesha,
WI
53188
|
|
Applicant Contact |
Helen Peng |
Correspondent |
GE Medical Systems, L.L.C. |
3000 N Grandview Blvd |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Helen Peng |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/16/2016 |
Decision Date | 12/16/2016 |
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
|
|
|