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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K191713
Device Name CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Applicant
Omega Medical Imaging, LLC
3400 St. Johns Parkway, Suite 1020
Sanford,  FL  32771
Applicant Contact John Newman
Correspondent
Omega Medical Imaging, LLC
3400 St. Johns Parkway, Suite 1020
Sanford,  FL  32771
Correspondent Contact John Newman
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OWB  
Date Received06/26/2019
Decision Date 10/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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