AccessGUDID - DEVICE: MedDream (04779049590105)

GUDID

Device Identifier (DI) Information

Brand Name: MedDream
Version or Model: 7.5.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: MEDDREAM UAB

Primary DI Number: 04779049590105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 984975648 *Terms of Use

Device Description: MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case-related non-image documents, archives them as DICOM data, and serves as a vendor-neutrall archive. It supports the physician in diagnosis. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. MedDream is a HTML based package for PACS server which is designed to aid professionals in every day's decision-making process, connecting all the medical data into a unified and fast performing network. MedDream ensures a fast and reliable way to search, present and analyze the medical data (images and video files) on various devices: computers, smart phones, tablets and so forth.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40943	Radiology picture archiving and communication system workstation	A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 296e071e-fa5f-407c-9331-e01d5b98eccf
Public Version Date: May 13, 2025
Public Version Number: 4
DI Record Publish Date: May 19, 2020