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The MAGNETOM systems [MAGNETOM Avantofit, MAGNETOM Skyrafit] are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

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This document is a letter from the FDA to Siemens Medical Solutions USA, Inc. regarding their 510(k) premarket notification for the MAGNETOM Avanto and MAGNETOM Skyra devices. It confirms the substantial equivalence of these magnetic resonance diagnostic devices.

The document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text.

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