Intended Use

ClearRead +Confirm is intended to generate an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.

Technology

ClearRead +Confirm uses a bone suppression mechanism to enhance visibility of lines and tubes on AP/PA chest radiographs. It is a post-processing software that shares a user platform for DICOM communication and system configuration with the ClearRead Bone Suppression predicate device.

Performance

Functional verification and development validation testing were performed to meet design requirements. Clinical validation via a multi-reader multi-case study showed that ClearRead +Confirm significantly reduces radiologists' time to localize tips of lines and tubes without loss of accuracy, confirming its utility as an adjunct tool for chest radiograph interpretation.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/15/2012

    1 month
  • 2

    FDA Approval

    12/27/2012

Other devices from RIVERAIN TECHNOLOGIES

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