Intended Use:

InferRead CT Lung software is used for receiving CT thoracic DICOM image from medical imaging storage devices. It marks the pulmonary nodules automatically. It can generate structural results, make comparison of the prior and the current image, and it has the functions for measuring and annotating in the viewer. It is used to assist the doctors for making diagnosis. It is not used for making diagnosis alone.

Warning:
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1) Warning：Nodule filter. Users shall be prudent and be confirmed when using the nodule filter function so as to avoid the problems that malignant nodules may not be found by the doctors, thereby leading to missed diagnosis.

2) Warning：Modify the type of nodule. The user may manually modify the type of nodule, and make careful confirmation, so as not to cause the problems such as wrong prediction of nodule found by the doctors at other levels. There should be a “Cancel” button to undo the user operation so as to avoid misdiagnosis.
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3) Software installation/upgrade/uninstallation: Software installation/upgrade/uninstallation must be operated by Inference Technology personnel, or relevant technical personnel approved by Inference Technology, so as to avoid causing the software to run in an abnormal state and the user's inability to use the software normally. treatment delays, etc.

4) Warning:  the software is only permitted to be used in the LAN network in case of the leak of patient data.

5) Warning: The Company provides hospital admin operation training service, and the operators or users shall receive necessary training before using the equipment so as to avoid misdiagnosis, missed diagnosis and false positive results.

6) Warning: The software is used for computer aided diagnosis. It is forbidden to directly use the software to generate diagnosis reports in case of missed diagnosis or false positive results.

7) Warning: Please inform Infervision when misdiagnosis/missed diagnosis occurs. If any serious incidents does occur, please report to Infervision and the competent authority in your country in time.

8) Warning: Please verify the corresponding labels before making diagnosis if there is no patient ID or patient name exists, in case of mismatching the patient information with the diagnosis result which may lead to misdiagnosis.