Product Name: InferOperate Suite
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Release version: 1

Indication 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), image fusion, 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.

Warnings:
(1) Software installation/upgrade/uninstallation must be performed by the InferVision technician or authorized technicians designated by InferVision to prevent issues such as abnormal software operation or user inability to use the software properly, which could lead to surgical planning failure.

(2) Our company provides user operation training services. Operators or users must undergo
necessary training before using the equipment to avoid delaying treatment.

(3) If any malfunction is detected in the reconstruction results, please report it to InferVision promptly.

(4) If reconstruction results cannot be obtained, please contact InferVision immediately.

(5) The accuracy of the image display results of this product may be affected by image quality (caused by scanning technique and patient-specific conditions), imaging equipment, and scanning parameters. The results are for physician reference only and cannot be used independently for surgical planning. Clinical physicians must integrate the patient’s medical history, symptoms, and clinical examination results for comprehensive planning.

(6) The measurement tools in this product are image-based and rely on pixel count, without any post-processing algorithms. The accuracy of measurements depends on the correct usage by the operator. If the measurement results are intended to assist in surgical planning, users must ensure that the measurement tools are used correctly to minimize measurement errors.

(7) This software is designed to assist human decision-making in treatment and should not be used directly as the sole basis for decisions.

(8) If any abnormalities are detected in image processing, please report them to InferVision promptly.

(9) If critical image data (such as Exam ID) is found missing in the system, do not use the data directly for clinical surgical planning.

(10) If reconstruction failures, segmentation omissions, or segmentation errors occur with this software, do not use its results. Refer to DICOM imaging for preoperative planning instead.

(11) To ensure patient privacy, this software will desensitize data stored on the server. Therefore, before treatment, please confirm that the selected case ID matches the hospital system to prevent errors.