Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K162990 |
Device Name |
Optima XR240amx |
Applicant |
GE Medical Systems, LLC |
3000 N. Grandview Blvd. |
Waukesha,
WI
53188
|
|
Applicant Contact |
Chris Paulik |
Correspondent |
GE Medical Systems, LLC |
3000 N. Grandview Blvd. |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Chris Paulik |
Regulation Number | 892.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/27/2016 |
Decision Date | 11/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|