ClearRead +Confirm is a software application that creates enhanced secondary digital chest X-ray images to help healthcare professionals confirm the placement of lines and tubes. This improves visibility on standard chest radiographs, aiding in timely and accurate patient management.
ClearRead +Confirm is intended to generate an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.
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.
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.
No predicate devices specified
Submission
11/15/2012
FDA Approval
12/27/2012
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