# K130228: Suiteheart

- Pathway: 510(k) (Traditional)
- Applicant: Neosoft, LLC
- Decided: Mar 20, 2013 after 50 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K940172 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121762: Cardiac VX, Ge Medical Systems, LLC (2013) Summary page 1.

## Indications for 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.

Source page: https://510kreport.com/device/K130228
Methodology: https://510kreport.com/methodology