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New Device Approval

ImageChecker® CT CAD Software System
(Model LN-1000) - P030012

 [Photo-Image Checker]

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: ImageChecker® CT CAD Software System (Model LN-1000)
Applicant: R2 Technology, Inc.
Address: 1195 W. Fremont Avenue
Sunnyvale, CA 94087
Approval Date: July 8, 2004
Approval Letter: http://www.fda.gov/cdrh/PDF3/p030012a.pdf

What is it? The ImageChecker® CT System is an image analysis system used by a radiologist to review Computed Tomography (CT) images of the chest. The system can help identify lung nodules that a radiologist may have missed.

How does it work? The ImageChecker® CT System uses Computer Aided Detection (CAD) software to analyze CT images that a radiologist has reviewed. Following a radiologist’s review of the case, the software reviews the CT images to highlight suspect nodules that the radiologist may have missed. The radiologist can then reassess the highlighted areas.

When is it used? The ImageChecker® CT System reviews CT images of the chest after they have been reviewed by a radiologist.

What will it accomplish? The ImageChecker® CT System can improve a radiologist’s ability to detect lung nodules in CT images by highlighting nodules that may have been missed.

When should it not be used? There are no known contraindications for the use of this device.

Additional information: Summary of Safety and Effectiveness Data and labeling are available at: http://www.fda.gov/cdrh/PDF3/p030012.html

Other:
FDA Talk Paper:
http://www.fda.gov/bbs/topics/answers/2004/ANS01300.html

FDA website on CT scans:
http://www.fda.gov/cdrh/ct/

National Institutes of Health (NIH) information on lung cancer:
http://www.nlm.nih.gov/medlineplus/lungcancer.html

National Cancer Institute (NCI) Information on lung cancer:
http://www.cancer.gov/cancertopics/types/lung

Updated August 19, 2004

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