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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 K062472
Device Name OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
Applicant
Source-Ray, Inc.
167 Keyland Ct.
Bohemia,  NY  11716
Applicant Contact RAY MANEZ
Correspondent
Source-Ray, Inc.
167 Keyland Ct.
Bohemia,  NY  11716
Correspondent Contact RAY MANEZ
Regulation Number892.1720
Classification Product Code
IZL  
Date Received08/24/2006
Decision Date 10/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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