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Home » FDA Clears Shimadzu’s Trinias Angiography Systems for U.S. Distribution
FDA Clears Shimadzu’s Trinias Angiography Systems for U.S. Distribution
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Shimadzu Medical Systems USA has received 510(k) clearance from the FDA to market its Trinias family of digital angiography systems. The line includes a ceiling-mounted, flour-mounted and biplane model.
All three systems incorporate Shimadzu's ultra-high speed SCORE PRO image-processing technology, which provides real-time evaluation of noise, devices and anatomy found in both fluoro and acquisition images.
Additionally, the devices’ SCORE StentView enables real-time display of stents in a fixed position, making it easier to assess potential relationships between overlapping stents or when re-expanding a stent using a balloon, the Torrance, Calif., company says.
Trinias also incorporates seven radiation dose-reduction features that marries the need for higher image quality with the most appropriate radiation dose. The device is available in the U.S. and Caribbean. — Nick Otto
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