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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
Predetermined Change
Control Plan Authorized		 No
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