# K220039: AutoSeg

- Pathway: 510(k) (Traditional)
- Applicant: Ai Medic, Inc.
- Decided: Jul 20, 2022 after 196 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 14 generations back to K913770 (1991). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200973: Synapse 3D Cardiac Tools, Fujifilm Corporaton (2020) Summary page 5.

## Most influential descendants
- K243158: TeraRecon Aorta.CT (1.1.0) (2025), 0 descendants of its own

## Indications for use
AutoSeg-H is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography). AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including: - Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries. - Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves. - 4-Chamber Analysis: which is intended for automatic extraction of the left atrium, left ventricle, right atrium, and right ventricle from CT.

Source page: https://510kreport.com/device/K220039
Methodology: https://510kreport.com/methodology