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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received01/07/2019
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
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