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Result : Searchterm 'GE medical' found in 0 term [ ] and 4 definitions [ ], (+ 17 Boolean[ ] results
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If a device is to be labeled MR Safe, the following information should be provided:
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Data demonstrating that when the device is introduced or used in the MRI environment (i.e. the MRI scan room) it does not pose an increased safety risk to the patient or other personnel,
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a scientifically-based rationale for why data are not necessary to prove the safety of the device in the MR environment (for example, a passive device made entirely of a polymer known to be nonreactive in strong magnetic fields).
If a device is to be labeled MR Compatible, the following information should be provided:
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Data demonstrating that when the device is introduced or used in the MRI environment, it is MR safe that it performs its intended function without performance degradation, and that it does not adversely affect the function of the MRI scanner (e.g. no significant ima ge artifacts or noise). Any ima ge artifact or noise due to the medical device should be quantified (e.g., % volume affected, signal to noise ratio),
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a scientifically-based rationale for why data are not necessary to prove the compatibility of the device in the MRI environment.
Test Conditions:
The static magnetic field strength ( Gauss (G) or Tesla (T)) to which the device was tested and demonstrated to be MRI 'safe', 'compatible', or 'intended for use in' should be related to typical machine ratings (e.g. 0.5 T, 1.5 T, 2.0 T, and shielded or unshielded magnet, etc).
The same conditions should be used for the spatial gradient ( field strength per unit distance (i.e., G/cm)) in which the device was tested and demonstrated to be 'safe', 'compatible', or 'intended for use in'.
Also the RF transmitter power used during testing of the device, should be related to this typical machine ratings. | | | | • For this and other aspects of MRI safety see our InfoSheet about MRI Safety. | | | • Patient-related information is collected in our MRI Patient Information.
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• View the NEWS results for 'MR Compatibility' (2).
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The company is a member of the Bracco Group, a highly innovative healthcare group and world leader in global integrated solutions for the diagnostic medical imaging field. The Bracco Group is headquartered in Milan, Italy. Its North American operations consist of Bracco Diagnostics and Bracco Research USA, both located in Princeton, New Jersey. Bracco Diagnostics is one of the fastest growing developers and marketers of diagnostic pharmaceuticals in North America, with products for various imaging applications, including Isovue® (iopamidol - X-ray contrast a gent), ProHance® ( gadoteridol - MRI contrast a gent), SonoVue® ( ultrasound contrast agent) and nuclear medicine products.
Gadoteridol has been available in Europe and the USA for several years.
Holder of the Marketing Authorization:
Bracco International B.V. - Strawinskylaan 3051 - 1077 ZX Amsterdam
The Netherlands. (Contact: Kirk Deeter, Phone: +NL-303-838-8708)
MRI Contrast Agents:
Contact Information
Please see Bracco Diagnostics, Inc.'s
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• View the DATABASE results for 'Bracco Diagnostics, Inc.' (2).
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MRI Contrast Agents:
Contact Information
MAIL
Guerbet
Boite postale 50400
95943 Roissy
Charles de Gaulle Cedex
FRANCE
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• View the DATABASE results for 'Guerbet S.A.' (7).
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The principal activity of this Japan-based Group, is to manufacture and sell diagnostic substances and rea gents. The Group's other activities include wholesale of rea gents and analysis equipment. The Group has one consolidated subsidiary located in Japan. Diagnostic substances and rea gents accounted for 83% of fiscal 2002 revenues; medical equipment, 12% and blood vessel contrast mediums, 5%.
Eiken Chemical Co., Ltd. distributes Feridex®.
Contact Information
MAIL
Eiken Chemical Co., Ltd.
1-33-8 Hongo, Bunkyo-ku
113-8408 Tokyo
JAPAN
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Contact Information
MAIL
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
USA
PHONE
+1-888-463-6332 (see also under E-MAIL)
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• View the DATABASE results for 'Food and Drug Administration' (9).
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• View the NEWS results for 'Food and Drug Administration' (20).
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