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Food and Drug Administration
 
http://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.
For more details please visit the FDA's 'Our Mission and Mandate'.
See also Class I II III Devices, Phase 1 2 3 4 Drug Trials and Legal Requirements.
Contact Information
MAIL Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
USA
PHONE +1-888-463-6332 (see also under E-MAIL)
FAX please visit the FDA FAX Directory
E-MAIL please visit the FDA Electronic Employee Directory
ONLINE www.fda.gov
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  News & More:
CMC Contrast Granted Orphan Drug Designation by the FDA for its Liver Specific MRI Contrast Media CMC-001
Wednesday, 27 November 2013   by news.gnom.es    
FDA approval will allow Sarpy MRI business to grow
Friday, 23 August 2013   by www.omaha.com    
FDA Approves PULSAR, SONATA, CONCERT
Thursday, 13 June 2013   by www.onlinetmd.com    
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State Food and Drug Administration
 
eng.sfda.gov.cn/eng (SFDA) The State Food and Drug Administration of the People's Republic of China was founded in November 2003 and is directly under the State Council. The State Food and Drug Administration is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation. For drug or medical device registration please see the SFDA's Regulatory Guide.
The agency is China's equivalent of the US Food and Drug Administration.
Contact Information
MAIL State Food and Drug Administration
A38, Beilishi Road
Beijing 100810
P.R. China
FAX 86-010-68310909
E-MAIL inquires@sda.gov.cn
ONLINE eng.sfda.gov.cn/eng

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MRI Resources 
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FerumoxtranInfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.
 
Short name: Ami 227, generic name: Ferumoxtran, (USPIO)
Ferumoxtran is a substance of the class of ultrasmall superparamagnetic iron oxide used as a lymph node specific contrast agent for MRI.
See also Combidex®, Sinerem® and Ultrasmall Superparamagnetic Iron Oxide.
Partner(s): Cytogen Corporation, National Cancer Institute. An approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. Advanced Magnetics, Inc. has submitted a complete response to the approvable letter received from the U.S. Food and Drug Administration, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005. In Europe, a Dossier (the European equivalent of a NDA) was submitted by Advanced Magnetics' European partner, Guerbet SA, to the European Medicines Evaluations Agency in December 1999. (Sinerem® is the brand name for this USPIO in Europe manufactured by Guerbet, Combidex® by Advanced Magnetics for the U.S. market)
Advanced Magnetics, Inc. changed its name in July 2007 to AMAG Pharmaceuticals Inc
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Further Reading:
  Basics:
Superparamagnetic Iron Oxide–enhanced MR Imaging of Head and Neck Lymph Nodes1
Comparison of Two Superparamagnetic Viral-Sized Iron Oxide Particles Ferumoxides and Ferumoxtran-10 with a Gadolinium Chelate in Imaging Intracranial Tumors
2002   by www.ajnr.org    
  News & More:
Optimized Labelling of Human Monocytes with Iron Oxide MR Contrast Agents
Sunday, 30 November 2003   by rsna2003.rsna.org    
Ultrasmall Superparamagnetic Particles of Iron Oxide-enhanced in vivo MRI of human atherosclerotic plaques.(.pdf)
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Aurora® 1.5T Dedicated Breast MRI SystemInfoSheet: - Devices -
Intro, 
Types of Magnets, 
Overview, 
etc.
 
From Aurora Imaging Technology, Inc.;
www.auroramri.com/mri/product/ The Aurora® 1.5T Dedicated Breast MRI System with Bilateral SpiralRODEO™ is the first and only FDA approved MRI device designed specifically for breast imaging. The Aurora System, which is already in clinical use at a growing number of leading breast care centers in the US, Europe, got in December 2006 also the approval from the State Food and Drug Administration of the People's Republic of China (SFDA).
'Some of the proprietary and distinguishing features of the Aurora System include: 1) an ellipsoid magnetic shim that provides coverage of both breasts, the chest wall and bilateral axillary lymph nodes; 2) a precision gradient coil with the high linearity required for high resolution spiral reconstruction;; 3) a patient-handling table that provides patient comfort and procedural utility; 4) a fully integrated Interventional System for MRI guided biopsy and localization; and 5) the user-friendly AuroraCAD™ computer-aided image display system designed to improve the accuracy and efficiency of diagnostic interpretations.'

Device Information and Specification
CLINICAL APPLICATION Breast MRI
CONFIGURATION Short bore compact
COILS Breast transmit receive (TR) coil
IMAGING MODES Bi-lateral RODEO fat suppression, high resolution Rotating Delivery of Excitation Offresonance Spiral, integrated targeting SW compatible with major MR guided intervention equipment.
TR 10 ms for gradient echo and less than 2,500 ms for T2 weighted spin echo
TE From 5 ms for RODEO Plus to over 80 ms, 120 ms for T2 sequences
SINGLE/MULTI SLICE Around 0.02 sec for a 256x256 image, 12.4 sec for a 512 x 512 x 32 multislice set
FOV 20 - 36 cm, max. elliptical 36 x 44 cm
MEASURING MATRIX 512 x 512
MAGNET TYPE Superconducting
BORE DIAMETER
or W x H
64 cm diameter (gantry)
MAGNET WEIGHT 8,500 lbs
H*W*D 240 x 188 x 163 cm
POWER REQUIREMENTS 150A/120V-208Y/3 Phase//60 Hz/5 Wire
COOLING SYSTEM Helium for magnet, distilled/de-ionized water for coil;
CRYOGEN USE Zero boil off rate
FIELD STRENGTH 1.5 T
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Further Reading:
  Basics:
AURORA MRI System® Site Planning Guide
   by www.thorpeconstruction.com    
  News & More:
Aurora Imaging Technology Announces Approval in China
   by salesandmarketingnetwork.com    
Aurora Imaging Technology, Inc. Release: Results of a Multi-Center Trial Demonstrates Superior Diagnostic Performance of the Aurora® 1.5T Dedicated Breast MRI System Over Whole-Body Breast MRI
Monday, 1 October 2012   by www.biospace.com    
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Radiology  (7) Open this link in a new windowUltrasound  (9) Open this link in a new window
Class I, II, III Devices
 
Classification by the Food and Drug Administration of medical devices according to potential MRI risks or hazards.

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Further Reading:
  Basics:
A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems
   by govpulse.us    
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