Medical Ultrasound Imaging
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Searchterm 'In Phase' found in 24 articles
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European Medicines Agency
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.

Contact Information
MAIL
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
PHONE
+31 (0)88 781 6000
Food and Drug Administration
https://www.fda.gov/default.htm (FDA) An agency of the US federal government established by Congress in 1912 and presently part of the US Department of Health and Human Services. The FDA gives classifications of medical devices according to potential risks and controls the safety of marketed drugs.

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials and US FDA 510k Document.
Contact Information:
AU5 EPI
www.esaote.com/products/ultrasound/au5/products1.htm From ESAOTE S.p.A.;
'The AU5 EPI is an ultrasound system for multi-disciplinary use that incorporates all the transducer technologies (linear, convex, phased array, and annular array) adapted to today's most diverse diagnostic requirements. Furthermore it offers the most modern and advanced techniques available today on the market.'

EsaTune
www.esaote.com/products/ultrasound/esatune/products1.htm From ESAOTE S.p.A.;
'The AU5 EPI is an ultrasound system for multi-disciplinary use that incorporates all the transducer technologies (linear, convex, phased array, and annular array) adapted to today's most diverse diagnostic requirements. Furthermore it offers the most modern and advanced techniques available today on the market.'

FFsonic UF-5800A
www.fukuda.co.jp/fukuda_e/products/uf-5800a.html From Fukuda Denshi Co., Ltd.;
'Phased array probes made available for High resolution imaging of full cardiovascular examinations.
By adding Linear and Convex probes, the examination areas are extended to Abdominal and OB/GYN applications.
B-mode (1, 2 displays), M, and B/M-modes can be individually shown.
Optional Doppler unit available for observation of Blood flow information in pulsed and continuous wave Doppler.
Portable with IP (Image Processing), Full Keyboard, and track ball are standard.'

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