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FDA Clears First Diagnostic Radiology Application for Mobile Devices

Provides wireless access to medical images for iPhone, iPad users

SILVER SPRING, Md. Feb. 4, 2011

http://photos.prnewswire.com/prnh/20090824/FDALOGO

The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

William Maisel

Cleveland

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician’s ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.

For more information:

Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

Media Inquiries: Erica Jefferson, 301-796-4988; [email protected]

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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