suiteHEART - suiteHEART® Software is intended to assist - NEOSOFT LLC

Duns Number:079151785

Device Description: suiteHEART® Software is intended to assist trained clinical personnel in the qualification suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.

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More Product Details

Catalog Number

-

Brand Name

suiteHEART

Version/Model Number

4.0.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 2017

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

K130228

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

f042d997-438d-4bad-88d5-d3dab84cda78

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOSOFT LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10