# K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Apr 4, 2022 after 229 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 8 generations back to K945512 (1995). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203256: Imbio RV/LV Software, Imbio, LLC (2021) Summary page 5.

## Most influential descendants
- K232613: CT Cardiomegaly (2024), 1 descendant of its own
- K243859: PRAEVAorta®2 (2025), 0 descendants of its own
- K231149: qXR-CTR (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K212624
Methodology: https://510kreport.com/methodology