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Turner Imaging Systems Submits Smart-C for FDA 510K Approval

OREM, UTAH, USA, February 7, 2019 /EINPresswire.com/ -- Turner Imaging Systems has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for its Smart-C Portable Fluoroscopy and X-Ray Imaging Device.

Once it receives FDA clearance Turner Imaging Systems plans to market the Smart-C Worldwide and will continue to seek regulatory clearances in other countries where appropriate.

The first-of-its-kind Smart-C-arm x-ray imaging device will allow medical personnel to do x-ray imaging of a patient’s extremities at the point of care — whether that’s in a hospital, surgical suite, clinic, post-acute care center or in the field for humanitarian missions.

What makes this device unique is its portability. The patent-pending Smart-C weighs only 16 pounds so that it can be hand carried to the point of care, no need for special equipment to wheel the device around. Its collapsible design makes Smart-C ideal for travel and storage. It’s also battery-powered, so there are no cords and no need for a power supply, making it ideal for medical imaging in the field. In addition, the x-ray device has an integrated surgical platform. The fully wireless system with its independent articulating arm and monitor provides all the capability of competing mini C-arms while providing flexibility for any healthcare setting.

Using sophisticated imaging algorithms, the Smart-C will provide high-quality imaging at the point of care. The Smart-C’s more flexible design will streamline care for the 35 percent of 47.5 million annual ER visits that require radiology and 300,000 sports-related injuries, as well as accommodating the space constraints of today’s surgery suites and outpatient settings.

“The Smart-C will revolutionize how and where doctors use x-rays,” said D. Clark Turner, Ph.D., founder and CEO of Turner Imaging Systems. “We envision the Smart-C being particularly useful for humanitarian aid workers, including Doctors Without Borders. Other specialty applications will include imaging in sports medicine, especially on the field or in the locker room, in-office outpatient orthopedic surgeries, care on military battlefields, extremity injections for pain management, mobile radiology units in rural areas, emergency rooms and much more.”
The Smart-C is not yet cleared by the FDA for sale in the U.S.

For more information about the Smart-C device, visit http://www.turnerxray.com.

ABOUT TURNER IMAGING SYSTEMS
Turner Imaging Systems develops and markets X-ray imaging systems that give the user the ability to acquire X-ray images wherever and whenever they are needed. Our latest product, the SMART-C, is a fully-functional mini-C-arm system that is battery operated and hand-transportable, improving the way fluoroscopy is performed. Our products expand the reach of X-ray imaging to the underserved and humanitarian efforts around the world. For more information, visit http://www.turnerxray.com

Rick White
Turner Imaging Systems
+1 801-796-2951
email us here

Distribution channels: Healthcare & Pharmaceuticals Industry


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