FDA 510(k) Clearance for Dual Tuned Head Coils 3T

Our Dual Tuned Head Coils 3T got 510(k) clearance and are now available on the US market.

The dual tuned volume coil for B0-field strength 3T allows the acquisition of 1H images in combination with a second nucleus. This includes the following multi-nuclei coil options:

  • 31P/1H Head Coil
  • 23Na/1H Head Coil
  • 13C/1H Head Coil

All coils feature quadrature polarisation for both nuclei. If supported by the MR system and the X nucleus, the coil can be used in 1H decoupled MR experiments. It comes with sliding mechanism for patient positioning: This allows the coil to be conveniently slid over the head of the patient already lying down. High level patient comfort is supported by a mirror and a coil design with open back. The mirror orientation can be flexibly changed to front or back without the use of any tools. The coil has an inner diameter of 26 cm and with only 7 kg weight, it is easy to position.

In addition to the USA, several coils are also authorized for use in EU, Switzerland, Great Britain, and Canada. Several coil designs are also approved for use in Australia. For detailed questions about approval in a specific country please contact us.

 

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