Alt tag

HealthCXR Device

  • X-Ray
  • Chest
  • Worklist Prioritisation
  • Pleural Effusion

The HealthCXR Device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. The software automatically identifies suspected findings suggestive of pleural effusion on chest x-rays and notifies PACS/ workstation of the presence of the critical findings.

The HealthCXR is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. The software automatically identifies suspected findings suggestive of pleural effusion on chest x-rays and notifies PACS/ workstation of the presence of the critical findings.

Nanox viewer

Images shown for illustrative purposes only.

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Potential reduced misses

For Pleural Effusion the HealthCXR device detection met the triage performance goal (above 95% AUC, and above 93% levels of sensitivity and specificity).2

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~26% and ~20% faster nodule search time

ClearRead CT technology helps radiologists see through the complexity to better detect abnormalities.1,2

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Higher inter-reader agreement rates2

Clinical Workflow

Nanox workflow

For CalanticTM software version 1.0.0, no prior study will be examined.
*Part of Nanox AI's pneumothorax & pleural effusion triage solution.

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    AP or PA chest x-ray image

    Image transformation of 0, 90, 180 or 270 degrees

    A study with no more than 15 series

    A series with no more than 5 images

    If a pleural effusion is found in a chest x-ray, the software notifies PACS/workstation of the presence of this critical finding. In addition, the software provides visual output to the user intended to aid in the detection or ruling out of a pleural effussion.

      Vendor
      Nanox AI.

      EU risk class and CE marking
      HealthCXR Device has CE marking (CE2195) and risk class IIa.

      Reimbursement status
      Not reimbursed.

      Contraindications
      HealthCXR device should not be used to analyze scans of patients under 18 years old, scans which are not AP or PA chest x-ray, scans with severe missing image artifacts, scans missing parts of the chest cavity or scans that are unnaturally monochrome in nature (too black or too white). Non-standard scans may skew analysis results, and if such scans are sent to HealthCXR device, physicians should disregard results from the scans.

      Patient Target Group
      Patients 18 years and older.

      Limitations

      • The HealthCXR device is limited to the analysis of Chest X-ray scans.
      • The HealthCXR device does not analyze scans of patients under 18 years of age.
      • The determination of patient’s age is limited to reading the Birth Date and Study Date.
      • DICOM attribute, or Patient’s Age DICOM attribute.
      • The device does not analyze images that are not AP or PA Chest X-Rays.
      • The device has limited capabilities to identify inadequate technical quality of x-ray images like image distortion, or presence of artifacts.
      • The device has limited capability to handle image rotations that are not 0, 90, 180, or 270 degrees.
      • The device does not process a study when the number of series exceeds 15.
      • The device does not process a series when the number of images exceeds 5.
        1.
        Instruction for Use HealthCXR Triage Device, software version 1.0
        2.
        FDA Summary K192320
        App gallery wave image
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