# K260973: InferOperate Suite

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.
- Decided: Jul 7, 2026 after 105 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: 16 generations back to K913770 (1991). 138 ancestors in all.
No later device cites it as a predicate yet.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250237: InferOperate Suite, Beijing Infervision Healthcare Medical Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
InferOperate Suite 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, including both preoperative surgical planning and intraoperative image display. InferOperate Suite accepts DICOM compliant medical images acquired from a variety of imaging devices. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. It provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), surface rendering, measurements, surgical planning, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures. The processing may include the generation of preliminary segmentations of anatomy using software that employs machine learning and other computer vision algorithms, as well as interactive segmentation tools, etc. InferOperate Suite is designed for use by trained professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. InferOperate Suite utilizes machine learning-based algorithms for adult patients undergoing CT chest, abdominal, or pelvic scans. For image data of other anatomical regions or modalities, patients under 21 years of age, or patients with unknown age, we provide non-ML software functions, such as STL viewer.

Source page: https://510kreport.com/device/K260973
Methodology: https://510kreport.com/methodology