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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, Stationary
510(k) Number K150506
Device Name ELIAN Digital Diagnostic X-ray System
Applicant
Osko, Inc.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact WANG CHOI
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
KPR  
Date Received02/26/2015
Decision Date 04/08/2015
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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