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The following MAGNETOM systems:

MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio

with syngo Expert—i option described in this premarket notification are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.

The syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.

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The provided text is related to a 510(k) premarket notification for the "MAGNETOM Systems with syngo Expert-i option." This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and outlining the intended use of the device. It does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.

The document details the device's general intended use as a magnetic resonance diagnostic device (MRDD) for producing various types of images and spectra to assist in diagnosis, and for imaging during interventional procedures. The "syngo Expert-i option" is described as a software feature that allows remote assistance for MRI users to perform scans faster and with better quality.

Therefore, I cannot provide the requested information from the given text. This document is a regulatory submission for substantial equivalence, not a performance study report.

To answer your request, a document detailing performance testing, clinical studies, or engineering verification and validation reports would be necessary.

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