# K231683: inHEART Models

- Pathway: 510(k) (Traditional)
- Applicant: Inheart, Sas
- Decided: Feb 29, 2024 after 265 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: 15 generations back to K913770 (1991). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220727: inHEART MODELS, Inheart, Sas (2022) Summary page 4.

## 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. * inHEART Models AI software module is indicated for adults only and is designed for CT images only. CONTRAINDICATIONS: This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Source page: https://510kreport.com/device/K231683
Methodology: https://510kreport.com/methodology