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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 K162011
Device Name MedDream
Applicant
Softneta Uab
K.Barausko St. 59
Kaunas,  LT 51423
Applicant Contact LAURA BARONIENE
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/21/2016
Decision Date 10/14/2016
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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