DicomForward - Basic DICOM gateway - Radius

Duns Number:080220305

Device Description: Basic DICOM gateway

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More Product Details

Catalog Number

-

Brand Name

DicomForward

Version/Model Number

3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

LMD

Product Code Name

System, Digital Image Communications, Radiological

Device Record Status

Public Device Record Key

4c36220d-313d-4a53-bba4-5c9460f87f24

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RADIUS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6