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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, Mobile
510(k) Number K163063
Device Name UC-5000 Mobile X-Ray
Applicant
Source-Ray, Inc.
50 Fleetwood Ct.
Ronkonkoma,  NY  11779
Applicant Contact RAY MANEZ
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received11/02/2016
Decision Date 12/12/2016
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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