The product is pending 510(k) clearance, and is not yet commercially available in the United States. Its future availability cannot be guaranteed.
MAGNETOM AvantoFit, A BioMatrixSystem, and MAGNETOM SkyraFit, A BioMatrixsystem, are still under development and not commercially available yet. Their future availability cannot be ensured.
MR scanning has not been established as safe for imaging fetuses and infants less than two years of age. The responsible physician must evaluate the benefits of the MR examination compared to those of other imaging procedures.