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News  (44)  
 
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.

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
ONLINE
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Further Reading:
  News & More:
KinetiCor Wins FDA 510(k) Clearance for Motion Correction System for Siemens MAGNETOM Skyra 3T Scanner
Wednesday, 19 February 2020   by finance.yahoo.com    
World's First Portable MRI Cleared by FDA
Monday, 17 February 2020   by www.medgadget.com    
GE Healthcare announces FDA approval of macrocyclic MRI contrast agent Clariscan
Monday, 4 November 2019   by www.itnonline.com    
FDA Expands Pediatric Age Range for MultiHance Contrast Agent
Tuesday, 30 January 2018   by www.empr.com    
Searchterm 'Food and Drug Administration' was also found in the following services: 
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Radiology  (7) Open this link in a new windowUltrasound  (9) Open this link in a new window
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
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MRI Resources 
Cardiovascular Imaging - Musculoskeletal and Joint MRI - Hospitals - Pacemaker - RIS - Colonography
 
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    
SPL Medical starts clinical trial with contrast agent ferrotran
Tuesday, 11 February 2020   by www.radboudumc.nl    
SPL Medical receives approval for Clinical Trial with contrast agent Ferrotran® in 10 top radiology centers.
Friday, 15 March 2019   by ferrotran.com    
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.
 
www.auroramri.com/mri/product/ From Aurora Imaging Technology, Inc.;
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 AuroraCADâ„¢ computer-aided image display system designed to improve the accuracy and efficiency of diagnostic interpretations.'
Device Information and Specification
CLINICAL APPLICATION
CONFIGURATION
Short bore compact
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
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;
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Further Reading:
  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    
Searchterm 'Food and Drug Administration' was also found in the following services: 
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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    
MRI Resources 
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