FDA Clears Three New Digital Angiography Systems from Shimadzu

Shimadzu Medical Systems USA has announced that its new digital angiography system family has received FDA 510(k) clearance. The family comprises the ceiling-mounted Trinias, the floor-mounted Trinias, and the Biplane models.

Background

Shimadzu Corporation, founded in 1896 in Kyoto, Japan, is a global provider of medical diagnostic equipment including conventional, interventional, and digital X-ray systems.

All the newly cleared systems incorporate Shimadzu’s ultra-high speed SCORE PRO image processing technology, one of many features oriented toward workflow efficiency. The company says its SMART Design delivers the intuitive functionality required to respond instantly to physician and operator commands. The Shimadzu SCORE Imaging process dramatically enhances the fluoroscopic image while maintaining ALARA (As Low As Reasonably Achievable) dose considerations for all clinical staff.

Specifically then, Trinias, designed as an angiographic interventional system,¬†offers a new 12″ “CROSSOVER” flat panel detector for multi-procedure versatility that accommodates any type of angiography procedure. Combined with SCORE PRO image processing, the systems provide claimed excellent visibility and numerous image guidance functions, as well as sophisticated 3D application techniques. Real-time performance is optimized specifically for increasing patient throughput, minimizing cost, and improving patient outcomes.

Designed also as a cardiac interventional system, Trinias is equipped with 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.

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.

Patient safety is at the forefront of the new device family, with seven radiation dose reduction features that provide a system-wide tradeoff balance between acquiring higher image quality images at the most appropriate radiation dose. The systems have data mirroring and redundant filaments to ensure procedure continuity. The Shimadzu SCORE Imaging is designed for improved outcoes at the least amount of dose.

Designed with ergonomics and ease of use and access in mind, each system has been created to meet the demands of a cath lab and the needs of a patient with such exclusive features as Shimadzu’s interventional designed triple pivot, a six axis in line C-arm mount, and a multi-insertion ceiling suspended C-arm.

Source: Shimadzu Medical Systems USA, PR Newswire

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