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510(k) Data Aggregation
K Number
K130228Device Name
SUITEHEART
Manufacturer
Date Cleared
2013-03-20
(50 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEOSOFT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
suiteHEART is an analytical software tool. which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 star analysis.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
Device Description
suiteHEART is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. suiteHEART can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in cine mode to facilitate visualization.
Measurement tools on the report interface include: point, distance, area, and volume measurements (including ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements). Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, T2 Star analysis, and patent foramen ovale (PFO) analysis.
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