Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K190024 |
Device Name |
Smart-C |
Applicant |
Turner Imaging Systems, Inc. |
1119 South 1680 West |
Orem,
UT
84058
|
|
Applicant Contact |
Michael Drake |
Correspondent |
Turner Imaging Systems, Inc. |
1119 South 1680 West |
Orem,
UT
84058
|
|
Correspondent Contact |
D. Clark Turner |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/07/2019 |
Decision Date | 09/27/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|