Instrumentarium’s Datex-Ohmeda division announced that it has received Food and Drug Administration 510(k) clearance for its Aestiva/5 MRI anesthesia machine, which is suitable for use in MRI environments.
Aestiva/5 MRI has been tested and validated to perform according to published specifications up to the 300-Gauss line of a 1.5-tesla active-shielded magnet, according to the Tewksbury, MA-based firm. The device is available for sale in the United States and is pending clearances in the Canadian and European markets, according to the vendor.
By AuntMinnie.com staff writersJuly 19, 2000
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