# K233457: RUS

- Pathway: 510(k) (Traditional)
- Applicant: Hutom, Inc.
- Decided: Jul 12, 2024 after 266 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). 137 ancestors in all.
No later device cites it as a predicate yet.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212896: Visible Patient Suite, Visible Patient, Sas (2021) Summary page 4.

## Indications for use
RUS is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients. RUS accepts DICOM compliant medical images acquired from iodine contrast-enhanced abdomen CT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments, including path definition through vascular and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K233457
Methodology: https://510kreport.com/methodology