MedDream NA

GUDID 04779049590105

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.

MEDDREAM UAB

Medical image management system

• Primary Device ID: 04779049590105
• NIH Device Record Key: 296e071e-fa5f-407c-9331-e01d5b98eccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedDream
• Version Model Number: 7.5.1
• Catalog Number: NA
• Company DUNS: 984975648
• Company Name: MEDDREAM UAB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 206 681-6822
• Email: laura.baroniene@softneta.com
• Phone: 206 681-6822
• Email: laura.baroniene@softneta.com
• Phone: 206 681-6822
• Email: laura.baroniene@softneta.com
• Phone: 206 681-6822
• Email: laura.baroniene@softneta.com
• Phone: 206 681-6822
• Email: laura.baroniene@softneta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04779049590105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162011

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-17
• Device Publish Date: 2020-05-19