From Hitachi Medical Corporation (HMC), sales, marketing and service in the US by Hitachi Medical Systems America Inc.
The HI VISION™ 5500 - EUB-5500 fully digital ultrasound system delivers the latest generation of signal processing technology, sophisticated transducer design, and a host of features and options for advanced imaging capabilities across a wide range of clinical situations. This system is compatible with all Pentax ultrasound endoscopes.

From Hitachi Medical Corporation (HMC), sales, marketing and service in the US by Hitachi Medical Systems America Inc.;
Powerful, flexible, and fast, the HI VISION™ 8500 - EUB-8500 diagnostic ultrasound scanner combines leading edge technologies with user-oriented operation for exceptional imaging and functionality.
Available exclusively on the 8500, SonoElastography provides a new perspective on the physical properties of tumors and masses by determining and displaying the relative stiffness of tissue.

From Hitachi Medical Corporation (HMC);
The HI VISION™ 6500 - EUB-6500 high resolution digital ultrasound system offers advanced clinical imaging, enhanced operating efficiency, and remarkable clinical flexibility, all in robust and versatile configuration that simply represents a better clinical solution in a variety of real-world, real-work arenas.

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Hitachi Medical Systems America, Inc. (HMSA) provides a complete range of ultrasound-based systems covering the entire spectrum from compact black and white systems at entry price level up to premium class systems for the most demanding users. As a full-line supplier of medical imaging equipment in Japan, Hitachi Medical Corporation (HMC) founded HMSA to provide a direct link to the U.S. marketplace. Hitachi consolidates his distribution channels in the US by transferring the Hitachi line of Ultrasound products to HMSA in October of 2002. HMSA is responsible for the sales, marketing and service of all Hitachi Ultrasound products in the United States.

Ultrasound Systems:

European Medicines Agency (EMA) is a decentralized body of the European Union with headquarters in Amsterdam.
'The EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. The EMEA has a role in both, but is primarily involved in the centralized procedure. Where the centralized procedure is used, companies submit one single marketing authorization application to the EMEA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the Commission to be transformed into a single market authorization valid for the whole of the European Union.'
'Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonization.'

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials, and Drug Development and Approval Process USA.