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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K140797
Device Name IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
Applicant
Visbion Limited
Visbion House, Gogmore Ln.
Chertsey, Surrey,  GB KP16 9AP
Applicant Contact TOM FALCON
Correspondent
Visbion Limited
Visbion House, Gogmore Ln.
Chertsey, Surrey,  GB KP16 9AP
Correspondent Contact TOM FALCON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/31/2014
Decision Date 12/12/2014
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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