510(k) · Cleared
ClearedEFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Fortune.Ai, Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Apr 4, 2022 as substantially equivalent to K203256 (Imbio, LLC, 2021) after a 229-day review. Its family tree reaches back 8 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 4, 2022
- Review
- 229 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945512 (1995). 17 ancestors in all, the oldest K945428 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 7 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 6 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 5 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 4 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 3 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 2 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 1 generation backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- This deviceK212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK232613 CT CardiomegalyInnolitics, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK243859 PRAEVAorta®2Nurea · 2025
- Descendant · cites it directly · 0 of its ownK231149 qXR-CTRQure.Ai Technologies · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −7 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −6 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −5 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −4 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −3 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −2 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| −1 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| 0 (this device) | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| +1 | K232613 | CT Cardiomegaly | Innolitics, LLC | 2024 | — |
| +2 | K243859 | PRAEVAorta®2 | Nurea | 2025 | — |
| +1 | K231149 | qXR-CTR | Qure.Ai Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K203256 | Imbio RV/LV SoftwareSummary page 5…Manufacturer 510(K)# Imbio RV/LV Software Imbio, LLC K203256 The EFAI iCTR is equivalent to the Imbio RV/LV Software (K203256), manufactured by Imbio, LLC is provided as primary predicate… | 2021 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K232613 (Innolitics, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K203256.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 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 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior-anterior (PA) chest view using an artificial…
Read the full statement (142 words)
EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject.
The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior-anterior (PA) chest view using an artificial intelligence algorithm.
Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.
The system is suitable for adults between 20 - 80 years of age.
Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212624 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) 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/K212624
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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