Disclaimer: The synopsis and product information provided on Alpha.MD are derived from openFDA data and are for informational purposes only. This information may not be comprehensive, accurate, or up-to-date. Clinicians should exercise their own professional judgment in interpreting and using this information, and consult the official prescribing information for the most accurate and current details.
Description
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Indication and Usage
To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Approval History
FDA approved 2020
Includes history for all formulations of adalimumab
June 02, 2020
(Type 2 New Active Ingredient and Type 4 New Combination)
Frequently Asked Questions
How much does Humira cost without insurance?
J
John Doe
New York, US
Products:
Humira
Humira
J
John Doe
New York, US
Products:
Humira
Humira
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