Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K172550 |
Device Name |
OEC Elite |
Applicant |
GE OEC Medical Systems, Inc. |
384 Wright Brothers Drive |
Salt Lake City,
UT
84116
|
|
Applicant Contact |
Rachel Schandel |
Correspondent |
GE OEC Medical Systems, Inc. |
384 Wright Brothers Drive |
Salt Lake City,
UT
84116
|
|
Correspondent Contact |
Rachel Schandel |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/23/2017 |
Decision Date | 11/16/2017 |
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
|
|
|