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Shimadzu Medical obtains FDA 510(k) approval for three digital angiography systems

Shimadzu Medical Systems USA, a manufacturer of advanced imaging systems, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for three digital angiography systems.

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The new digital angiography system family includes ceiling-mounted Trinias, floor-mounted Trinias, and the Biplane models.

These systems feature Shimadzu’s ultra-high speed SCORE PRO image processing technology and provides excellent visibility and numerous image guidance functions, as well as sophisticated 3D application techniques.

Shimadzu claims that the SCORE Imaging process enhances the fluoroscopic image, while maintaining ALARA (As Low As Reasonably Achievable) dose considerations for all clinical staff. Smart Design delivers the intuitive functionality required to respond instantly to physician and operator commands.

Trinias is designed an angiographic interventional system, which features a new 12" CROSSOVER flat panel detector for multi-procedure versatility that accommodates any type of angiography procedure.

In order to increase patient throughput and improve patient outcomes, real-time performance is specifically optimized in these systems.

Trinias is also designed as a cardiac interventional system, which features a new 8" flat panel detector for cardiac-suited procedures as well as neuro exams. SCORE StentView can provide users improved visibility of existing stents in vessels.

Elements of SCORE imaging include SCORE PRO, SCORE RSM, SCORE StentView, SCORE StentView, SCORE 3D and SCORE CT.

SCORE PRO, a next-generation of image processing, provides optimal imaging by a real-time evaluation of noise, devices, and anatomy found in both fluoro and acquisition images. The software then determines the best image quality by optimizing devices and anatomy while eliminating noise.

SCORE RSM is an exclusive Shimadzu feature that allows for 100% motion correction during an acquisition.

SCORE StentView specifically supports percutaneous coronary intervention procedures. It enables the display of stents in a fixed position in real-time, which makes it easier to assess potential relationships between overlapping stents or when re-expanding a stent using a balloon.

A real-time application now uses DICOM images and requires no special post-processing workstation. This saves valuable room space and creates a real-time interventional environment for physicians and staff at tableside.

SCORE 3D uses Shimadzu advanced C-arm design and 60 degree per second rotation to acquire 3-D images in a matter of seconds.

SCORE CT is for observing cross sectional images of low-contrast procedures, such as tumor stains, visceral anatomy, neuro-interventional planning, and more.


Image: Shimadzu Medical Systems’ Trinias digital angiography system. Photo: Courtesy of PRNewswire/Shimadzu Medical Systems USA