Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K213715 |
Device Name |
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition |
Applicant |
GE Medical Systems,LLC |
3000 N Grandview Blvd. |
Waukesha,
WI
53188
|
|
Applicant Contact |
Katelyn Rowley |
Correspondent |
GE Medical Systems,LLC |
3000 N Grandview Blvd. |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Katelyn Rowley |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/24/2021 |
Decision Date | 12/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|