Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K191777 |
Device Name |
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
Applicant |
GE Medical Systems, LLC |
3000 N. Grandview Blvd |
Waukesha,
WI
53188
|
|
Applicant Contact |
Laura Turner |
Correspondent |
GE Medical Systems, LLC |
3000 N. Grandview Blvd |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Laura Turner |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/02/2019 |
Decision Date | 07/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|