510(k) · Cleared
ClearedEFAI ChestSuite XR Pleural Effusion Assessment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Fortune.Ai, Co., Ltd. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Sep 8, 2022 as substantially equivalent to K192320 (Zebra Medical Vision, Ltd., 2019) after a 56-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Sep 8, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 2 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 1 generation backK192320 HealthCXRZebra Medical Vision, Ltd. · 2019
- This deviceK222076 EFAI ChestSuite XR Pleural Effusion Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −3 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −2 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| −1 | K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019 | — |
| 0 (this device) | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
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 QFM? 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 QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 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 |
|---|---|---|---|
| * | K192320 | HealthCXRSummary page 6…oduct Code QFM Regulatory Class II 3. Predicate Device Proprietary Name HealthCXR Premarket Notification K192320 Classification Name Radiological Computer-Assisted Prioritization Software For Lesi… | 2019 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K192320.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
EFAI Chestsuite XR Pleural Effusion Assessment System is a software workflow tool designed to aid the clinical assessment of adult (18 years of age or older) Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. EFAI Chestsuite XR Pleural Effusion Assessment System analyzes cases using an artificial intelligence algorithm to identify suspected findings on chest x-ray images taken in PA position. It makes…
Read the full statement (132 words)
EFAI Chestsuite XR Pleural Effusion Assessment System is a software workflow tool designed to aid the clinical assessment of adult (18 years of age or older) Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. EFAI Chestsuite XR Pleural Effusion Assessment System analyzes cases using an artificial intelligence algorithm to identify suspected findings on chest x-ray images taken in PA position. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI Chestsuite XR Pleural Effusion Assessment System is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pleural effusion or otherwise preclude clinical assessment of X-Ray cases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222076: EFAI ChestSuite XR Pleural Effusion Assessment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222076
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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