• Object ID: 00000018WIA303F1870GYZ
  • Topic ID: id_40023483 Version: 1.9
  • Date: Jul 7, 2022 6:57:38 PM

Intended use

The SIGNATM Voyager system is a whole body magnetic resonance scanner used to produce images of the inside of the human body that help aid the diagnosis of disease. In a clinical setting, Magnetic Resonance imaging (MRI) may be used to distinguish diseased or compromised tissue from normal tissue.

MRI technology is routinely used to help the diagnosis in diseases such as oncology, stroke, heart and peripheral vascular disease, pediatric diseases, etc. MRI technology in general, however, is not limited to specific diseases, stage and condition of diseases, or clinical forms.

MRI technology is intended to be used by the healthcare professionals (clinicians and trained technologists) following good clinical practice. It can be used in broad patient population including adults, children and infants , following good clinical practice.