# K240786: AutoChamber

- Pathway: 510(k) (Traditional)
- Applicant: HeartLung Corporation
- Decided: Oct 10, 2024 after 202 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: 10 generations back to K913770 (1991). 73 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 75 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.
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool, Philips Medical Systems (Cleveland), Inc. (2009) Summary page 5.

## Most influential descendants
- K252029: AI-CVD (2025), 0 descendants of its own

## Indications for use
The AutoChamber software is an opportunistic AI-powered quantitative imaging tool that measures and reports cardiac chambers volumes comprising left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and left ventricular wall (LVW) from non-contrast chest CT scans including coronary artery calcium (CAC) scans and lung CT scans. AutoChamber is not intended to rule out the risk of a cardiovascular disease, and the results should not be used for any purpose other than to enable physicians to investigate patients that AutoChamber shows signs of enlarged heart (cardiomegaly), enlarged cardiac chambers, and left ventricular hypertrophy (LVH) whose conditions are otherwise missed by human eyes in non-contrast chest CT scans. AutoChamber similarly measures and reports LA, LV, RA, RV, and LVW in contrast-enhanced coronary CT angiography (CCTA) scans. Additionally, AutoChamber measures and reports cardiothoracic ratio (CTR) in both contrast and non-contrast CT scans where the entire thoracic cavity is in the axial field of view. AutoChamber quantitative imaging measurements are adjusted by body surface area (BSA) and are reported both in cubic centimeter volume (cc) and percentiles by gender using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). AutoChamber should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans of the chest, such as CAC and lung CT scans, as well as CCTA scans. Using AutoChamber quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate asymptomatic patients who are unaware of their risk of heart failure, atrial fibrillation, stroke and other life-threatening conditions associated with enlarged heart, enlarged cardiac chambers, and LVH that may warrant additional risk-assessment or follow-up. AutoChamber quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.

Source page: https://510kreport.com/device/K240786
Methodology: https://510kreport.com/methodology