# K052164: Magnetom Systems with Software Syngo MR 2006A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 4, 2005 after 56 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). 7 ancestors in all.
312 later devices descend from it; 2 cite it directly.
22 of 320 devices in its family (counting itself) have 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 2.
- K041112: Magnetom Espree System, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K050199: Magnetom Symphony a Tim System, Siemens Medical Solution (2005) Summary page 2.
- K050200: Magnetom Trio a Tim System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K062454: Magnetom Systems - I-Class and T-Class Releases (2006), 308 descendants of its own
- K072237: Magnetom Verio (2007), 300 descendants of its own
- K082427: Syngo MR B17 (2008), 229 descendants of its own
- K071925: Magnetom Essenza (2007), 228 descendants of its own
- K101347: Magnetom Aera; Magnetom Skyra (2010), 224 descendants of its own

## Indications for use
The "MAGNETOM Espree" the "MAGNETOM Avanto" the "MAGNETOM Symphony a Tim System" the "MAGNETOM Trio a Tim System" is 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. The "MAGNETOM Espree" the "MAGNETOM Avanto" the "MAGNETOM Symphony a Tim System" the "MAGNETOM Trio a Tim System" may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K052164
Methodology: https://510kreport.com/methodology