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 cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software 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.
Catalog Number
-
Brand Name
suiteHEART
Version/Model Number
4.0.7
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 02, 2019
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
K130228
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
b2296f90-f6a2-42b5-bb88-374e6c317172
Public Version Date
February 28, 2020
Public Version Number
2
DI Record Publish Date
November 21, 2018
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. | 10 |