# K062454: Magnetom Systems - I-Class and T-Class Releases

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Nov 3, 2006 after 73 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: 4 generations back to K971684 (1997). 8 ancestors in all.
308 later devices descend from it; 3 cite it directly.
22 of 317 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.
- K052164: Magnetom Systems with Software Syngo MR 2006A, Siemens Medical Solutions USA, Inc. (2005) Summary page 3.

## Most influential descendants
- 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
- K083166: Specialty Coils for the Magnetom Essenza (2009), 222 descendants of its own

## Indications for use
The MAGNETOM Systems - I-class and T-class releases 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 safe biopsy needles.

Source page: https://510kreport.com/device/K062454
Methodology: https://510kreport.com/methodology