MedDream

Basic Information

• Brand Name: MedDream
• Primary DI: 04779049590105
• Version / Model: 7.5.1
• Catalog Number: NA
• Company Name: SOFTNETA UAB
• Labeler DUNS: 681687243
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 1
• Public Version Date: 2020-05-27
• Public Version Status: New
• Public Device Record Key: 296e071e-fa5f-407c-9331-e01d5b98eccf

Device Description

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 Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60723	Medical image management system	A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04779049590105	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162011	000