# K052423: Magnetom Systems with Syngo Expert - I Option

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Jan 13, 2006 after 133 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971684 (1997). 9 ancestors in all.
199 later devices descend from it; 6 cite it directly.
1 of 209 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032428: Magnetom Avanto MR System, Siemens Medical Solutions USA, Inc. (2003) Summary page 3.
- K041112: Magnetom Espree System, Siemens Medical Solutions USA, Inc. (2004) Summary page 3.
- K050199: Magnetom Symphony a Tim System, Siemens Medical Solution (2005) Summary page 3.
- K050200: Magnetom Trio a Tim System, Siemens Medical Solutions USA, Inc. (2005) Summary page 3.
- K970852: Magnetom Project 024 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 3.
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 3.
- K993731: Sonata Gradients/Magnetom Symphony System, Siemens Medical Solutions USA, Inc. (1999) Summary page 3.
- K003192: Magnetic Concerto, Siemens Medical Solutions USA, Inc. (2000) Summary page 3.
- K013586: Magnetom Trio System, Siemens Medical Systems, Inc. (2001) Summary page 6.

## Most influential descendants
- K061964: Syngo Multimodality Workplace (2006), 180 descendants of its own
- K072728: Syngo Multimodality Workplace (2008), 178 descendants of its own
- K081734: Syngo Imaging (Version V31) (2008), 177 descendants of its own
- K092519: Syngo.X (2009), 176 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own

## Indications for use
The above listed MAGNETOM systems 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. 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. 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.

Source page: https://510kreport.com/device/K052423
Methodology: https://510kreport.com/methodology