510(k) · Cleared
ClearedEFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Fortune.Ai, Co., Ltd. · KPS System, Tomography, Computed, Emission
Cleared on May 31, 2022 as substantially equivalent to K040326 (Adac Laboratories, 2004) after a 186-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- May 31, 2022
- Review
- 186 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003264 (2000). 4 ancestors in all, the oldest K980715 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK003264 QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 2000
- 2 generations backK022428 Quantitative Blood Pool Spect (QBS)Adac Laboratories · 2002
- 1 generation backK040326 Autoquant PlusAdac Laboratories · 2004
- This deviceK213731 EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003264 | QPS/BPGS/Moco Processing Applications for Entegra Workstation | Ge Medical Systems F.I. Haifa | 2000 | — |
| −2 | K022428 | Quantitative Blood Pool Spect (QBS) | Adac Laboratories | 2002 | — |
| −1 | K040326 | Autoquant Plus | Adac Laboratories | 2004 | — |
| 0 (this device) | K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040326 | Autoquant PlusSummary page 4…Regulation Number: 21 CFR §892.1200 III. Predicate Device AutoQUANT® Plus manufactured by ADAC LABORATORIES under K040326 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K040326.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
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…
Read the full statement (104 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213731 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213731: EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213731
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026