Duns Number:681687243
Device Description: MedDream is a software medical imaging system used to receive DICOM images, scheduling inf 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.
Catalog Number
NA
Brand Name
MedDream
Version/Model Number
7.5.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162011
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
296e071e-fa5f-407c-9331-e01d5b98eccf
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |