EDDA TECHNOLOGY - IQQA-Liver is an image analysis software for - EDDA TECHNOLOGY, INC.

Duns Number:782779701

Device Description: IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT a IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT and MR scanners

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More Product Details

Catalog Number

-

Brand Name

EDDA TECHNOLOGY

Version/Model Number

IQQA-Liver Multimodality

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K131498

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

4acc49bf-e0aa-40e4-823f-7e63673b15d0

Public Version Date

October 07, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EDDA TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4