# K213731: EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: May 31, 2022 after 186 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003264 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040326: Autoquant Plus, Adac Laboratories (2004) Summary page 4.

## Indications for use
EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is an image processing software that provides analysis on DICOM images acquired from GE Medical Systems Nuclear Quantitative Perfusion SPECT software to support appropriately trained healthcare professionals in the evaluation and assessment of myocardial perfusions. It provides the following functionality: Segmentation of the Bull’s Eye images from the original DICOM Analysis of the Bull’s Eye images to help assess perfusion Custom settings to generate text reports The results of this processing may be used to aid in evaluating and assessing myocardial perfusions. The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECT software.

Source page: https://510kreport.com/device/K213731
Methodology: https://510kreport.com/methodology