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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K954172
Device Name X-RAY VISIONS
Applicant
Image Visions, LLC
400 Madison Ave.
New York,  NY  10017
Applicant Contact MIKE MESSEMER
Correspondent
Image Visions, LLC
400 Madison Ave.
New York,  NY  10017
Correspondent Contact MIKE MESSEMER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received09/05/1995
Decision Date 03/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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