# K130262: Magnetom Essenza with Syngo MR D14

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 1, 2013 after 28 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: 10 generations back to K971684 (1997). 47 ancestors in all.
11 later devices descend from it; 2 cite it directly.
3 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071925: Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 2.
- K083166: Specialty Coils for the Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.
- K100141: 14-Channel Extremity Coil for Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2010) Summary page 2.
- K060873: Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems, Sentinelle Medical, Inc. (2006) Summary page 2.

## Most influential descendants
- K152283: MAGNETOM Amira (2015), 9 descendants of its own
- K173600: MAGNETOM Amira (2017), 7 descendants of its own
- K163211: MAGNETOM Sempra with syngo MR E11S (2017), 7 descendants of its own
- K183221: MAGNETOM Amira, MAGNETOM Sempra (2019), 6 descendants of its own
- K210611: MAGNETOM Free.Max (2021), 4 descendants of its own

## Indications for use
The MAGNETOM ESSENZA with syngo MR D14 is indicated for use as magnetic resonance diagnostic devices (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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM ESSENZA 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.

Source page: https://510kreport.com/device/K130262
Methodology: https://510kreport.com/methodology