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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 K222320
Device Name MedDream
Softneta UAB
K.Barsausko str. 59
Kaunas,  LT 51423
Applicant Contact Laura Baroniene
Licensale Inc
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number892.2050
Classification Product Code
Date Received08/02/2022
Decision Date 12/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No