# K220727: inHEART MODELS

- Pathway: 510(k) (Traditional)
- Applicant: Inheart, Sas
- Decided: May 10, 2022 after 57 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 4.

## Most influential descendants
- K231683: inHEART Models (2024), 0 descendants of its own

## Indications for use
inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Source page: https://510kreport.com/device/K220727
Methodology: https://510kreport.com/methodology