# K232613: CT Cardiomegaly

- Pathway: 510(k) (Traditional)
- Applicant: Innolitics, LLC
- Decided: Feb 28, 2024 after 184 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: 9 generations back to K945512 (1995). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System, Ever Fortune.Ai, Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K243859: PRAEVAorta®2 (2025), 0 descendants of its own

## Indications for use
CT Cardiomegaly is a command line software application intended to be run on its own or as part of another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart. CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning 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 and transitional adolescents (18 to 21 years old but treated as an adult). Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease.

Source page: https://510kreport.com/device/K232613
Methodology: https://510kreport.com/methodology