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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 K170946
Device Name Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
Applicant
Skanray Technologies Private Limited
Plot 15-17
Hebbal Industrial Area
Mysore,  IN 570016
Applicant Contact Mahadevan J.
Correspondent
Elexes Medical Consulting Pvt Ltd.
#6494, Tralee Village Dr.
Dr Dublin,  CA  94568
Correspondent Contact Parul Chansoria
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
OWB  
Date Received03/30/2017
Decision Date 11/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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