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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.

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    
MRI Resources 
Musculoskeletal and Joint MRI - Homepages - Quality Advice - Open Directory Project - Claustrophobia - MRI Reimbursement
 
GE HealthcareMRI Resource Directory:
 - Manufacturers -
 
www.gehealthcare.com GE Healthcare is the result of the merger between GE Medical and Amersham Health in Nov. 2004, after GE acquired Amersham Health for 9.5 billion in Oct. 2003. Jeffrey R. Immelt, Chairman of the Board and Chief Executive of General Electric, said, 'Amersham's diagnostic pharmaceutical and life sciences business will add new, high growth platforms to GE Medical's diagnostic imaging, services and healthcare information technology businesses'. GE Healthcare, a UK company, is a unit of General Electric (NYSE: GE). GE Healthcare is a global leader in medical imaging, diagnostic imaging contrast agents, interventional procedures, healthcare services, and information technology. For more than 100 years, health care providers have relied on GE Medical Systems, now GE Healthcare, for high quality medical technology and productivity solutions. GE Healthcare, headquartered now at formerly seat of Amersham Health in Great Britain, operates facilities around the world. Global Operations include organizations on the Americas, Europe, and Asia, including India, Japan, Korea China, Thailand and Vietnam.

MRI Scanners:

MRI Contrast Agents:
Contact Information
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Further Reading:
  Basics:
GE Medical's new name: GE Healthcare
Friday, 6 February 2004   by milwaukee.bizjournals.com    
  News & More:
GE HealthCare introduces new MRI agent Pixxoscan
Friday, 28 April 2023   by www.medicaldevice-network.com    
GE Healthcare Names New 3.0T MRI System for Today's Healthcare Heroes
Monday, 13 December 2021   by www.itnonline.com    
GE Healthcare announces FDA approval of macrocyclic MRI contrast agent Clariscan
Monday, 4 November 2019   by www.itnonline.com    
GE Healthcare expands MRI contrast media product range in Europe with launch of macrocyclic agent ClariscanTM
Wednesday, 1 March 2017   by www.businesswire.com    
A*STAR & GE Healthcare Collaborate On Med Tech
Monday, 22 December 2014   by www.asianscientist.com    
MRI Resources 
Lung Imaging - MRCP - Equipment - Quality Advice - Non-English - Patient Information
 
Guerbet S.A.
 
www.guerbet.com/home_va.html The France-based Guerbet Group is highly specialized in contrast media for medical imaging. Its strategic goal is to be a key player in this market. Products include Dotarem (Magnetic Resonance Imaging) and Xenetix (X-ray Imaging).

MRI Contrast Agents:
Contact Information
MAIL
Guerbet
Boite postale 50400
95943 Roissy
Charles de Gaulle Cedex
FRANCE
PHONE
+33-1-45-91-50-00
FAX
+33-1-45-91-51-99
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Further Reading:
  Basics:
Guerbet Completes Acquisition of Mallinckrodt’s Contrast Media and Delivery Systems Business
Sunday, 29 November 2015   by www.itnonline.com    
  News & More:
Guerbet to Spotlight Diagnostic and Interventional Solutions at the 2023 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting
Tuesday, 3 January 2023   by www.itnonline.com    
Guerbet to Spotlight the Novel New Drug Elucirem (gadopiclenol) injection at RSNA22
Saturday, 26 November 2022   by www.itnonline.com    
Guerbet receives EMA acceptance of Elucirem™ as the Brand Name for Gadopiclenol
Monday, 13 June 2022   by www.prnewswire.com    
Gadopiclenol: positive results for Phase III clinical trials
Monday, 29 March 2021   by www.pharmiweb.co    
Searchterm 'contact' was also found in the following services: 
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IMRIS™MRI Resource Directory:
 - Manufacturers -
 
IMRIS® is a Canadian manufacturer of Magnetic Resonance Imaging Systems for use in neurosurgical operating rooms. The 1.5T intra-operative system, developed by IMRIS, is the only system of its kind in the world. This patented, intra-operative system, is designed so that the magnet moves over the patient for imaging (before, during and after surgery), and then is retracted to allow complete surgical access to the patient.

MRI Scanners:

Contact Information
MAIL
IMRIS®
435 Ellice Avenue
Winnipeg.MB
Canada R3B1Y6
PHONE
1-88-304-0114 or 204-983-6867
FAX
204-984-1850
ONLINE
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MRI Resources 
MRI Accidents - MRI Centers - MR Myelography - Musculoskeletal and Joint MRI - Mobile MRI - RIS
 
ISOL TechnologyMRI Resource Directory:
 - Manufacturers -
 
www.isoltech.co.kr ISOL Technology participated in the pioneering the Korea's MRI development since the early 1980's. In spite of the rapidly changing business environment, and severe competition in the overall medical market, ISOL Technology has grown steadily each year and has established itself as a major provider of Magnetic Resonance(MR) Imaging Systems in Korea.
ISOL Technology also has the largest market share of the domestic bone densitometry equipment sales and is currently in the early stages of development of the 61 channel MCG (Magnetocardiography) system with the R and D funds from the Korean Ministry of Commerce, Industry and Energy.

MRI Scanners:

0.35T to 0.5T:
1.5T:
3T:
Contact Information
MAIL
ISOL Technology
203 Neungpyeong-ri
Opo-eub, Gwangju-si, Gyeonggi-do
Zip Code : 464-892
Korea
PHONE
+82-2-2294-1800
FAX
+82-2-2295-1891
E-MAIL
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MRI Resources 
Resources - MRCP - Directories - Jobs - Used and Refurbished MRI Equipment - Raman Spectroscopy
 
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