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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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Radiology  (1) Open this link in a new window
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    
MRI Safety Resources 
Nerve Stimulator - Shielding - Cochlear Implant - Safety pool - Guidance
 
Mangafodipir TrisodiumInfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
Short name: Mn-DPDP
This MRI contrast agent is a chelate complex of the paramagnetic metal ion manganese (Mn) and fodipir. Mn-DPDP (Teslascan) shortens the longitudinal relaxation time and is used for the T1 weighted enhancement of MR images. Mangafodipir trisodium accumulates after intravenous injection in the healthy tissue of the liver and improves the detection, localization, characterization, and evaluation of lesions of the liver, pancreas, but can also be used in cardiac MRI.
See also Hepatobiliary Chelates and Teslascan®.
The United States Food and Drug Administration (FDA) has granted marketing clearance 1997, to Nycomed Amersham's MRI contrast medium. Nycomed/Amersham, now GE Healthcare markets the product under the trade name Teslascan®.

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• View the NEWS results for 'Mangafodipir Trisodium' (1).Open this link in a new window.
 
Further Reading:
  Basics:
Teslascan Pharmacology, Pharmacokinetics, Studies, Metabolism - Mangafodipir - RxList Monograph
   by www.rxlist.com    
Mangafodipir (Systemic)
2003   by www.drugs.com    
  News & More:
Diagnosis and staging of pancreatic cancer: comparison of mangafodipir trisodium-enhanced MR imaging and contrast-enhanced helical hydro-CT.
2002
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