SOFTNETA UAB

Address:K. Barsausko str. 59,Kaunas Kauno Apskritis,LT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

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MedDream - 04779049590105 Catalog Number : NA

Device Description : MedDream is a software medical imaging system used to receive DICOM images, sche MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians.Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data.

Device Class : 2

Duns Number: 681687243

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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