Literature DB >> 10291710

Magnetic resonance diagnostic device; panel recommendation and report on petitions for magnetic resonance reclassification and codification of reclassification--FDA. Final rule.

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Abstract

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to a petitioner reclassifying the magnetic resonance diagnostic device, from class III (premarket approval) into class II (performance standards). The order is being codified in the Code of Federal Regulations as specified herein.

Mesh:

Year:  1989        PMID: 10291710

Source DB:  PubMed          Journal:  Fed Regist        ISSN: 0097-6326


  8 in total

1.  MR imaging of RF heating using a paramagnetic doped agarose phantom.

Authors:  E M Shapiro; A Borthakur; R Reddy
Journal:  MAGMA       Date:  2000-06       Impact factor: 2.310

2.  Fast MRI of RF heating via phase difference mapping.

Authors:  Erik M Shapiro; Arijitt Borthakur; Michael J Shapiro; Ravinder Reddy; John S Leigh
Journal:  Magn Reson Med       Date:  2002-03       Impact factor: 4.668

3.  Simulation study on active noise control for a 4-T MRI scanner.

Authors:  Mingfeng Li; Teik C Lim; Jing-Huei Lee
Journal:  Magn Reson Imaging       Date:  2007-12-03       Impact factor: 2.546

4.  Cecal volvulus in pregnancy: report of a case and review of the safety and utility of medical diagnostic imaging in the assessment of the acute abdomen during pregnancy.

Authors:  Brian A Hogan; Carl J Brown; Jacqueline A Brown
Journal:  Emerg Radiol       Date:  2007-07-03

5.  Adaptive speech enhancement using directional microphone in a 4-T MRI scanner.

Authors:  Guohua Sun; Mingfeng Li; Brent W Rudd; Teik C Lim; Jeffrey Osterhage; Elizabeth M Fugate; Jing-Huei Lee
Journal:  MAGMA       Date:  2015-04-18       Impact factor: 2.310

Review 6.  Magnetic resonance imaging of the neonatal brain.

Authors:  Ariel Prager; Sudipta Roychowdhury
Journal:  Indian J Pediatr       Date:  2007-02       Impact factor: 1.967

7.  Effect of headphones on sevoflurane requirement for MRI.

Authors:  Mustafa Oğurlu; Mehmet Emin Orhan; Salih Çinar; Ertan Piri; Ercan Kurt; Necdet Sut; Alparslan Turan
Journal:  Pediatr Radiol       Date:  2012-08-12

Review 8.  New Insights into MR Safety for Implantable Medical Devices.

Authors:  Kagayaki Kuroda; Satoshi Yatsushiro
Journal:  Magn Reson Med Sci       Date:  2022-02-25       Impact factor: 2.760

  8 in total

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