FDA-Device2019-07-24Class II
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Elekta, Inc.
Hazard
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
Sold states
US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.
Affected count
12 units
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2019Don't want to check this manually?
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