# K071925: Magnetom Essenza

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 14, 2007 after 33 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971684 (1997). 9 ancestors in all.
228 later devices descend from it; 5 cite it directly.
19 of 238 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.
- K062454: Magnetom Systems - I-Class and T-Class Releases, Siemens Medi Cal Solutions, Inc. (2006) Summary page 2.
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 2.

## Most influential descendants
- K083166: Specialty Coils for the Magnetom Essenza (2009), 222 descendants of its own
- K103275: Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems (2011), 221 descendants of its own
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel (2014), 115 descendants of its own

## Recalls of this device
- Mar 30, 2012 · Not classified · Z-1675-2012: There is an error in the compatibility data sheet which is part of the System Owner Manual

## Indications for use
The MAGNETOM Essenza 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. 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/K071925
Methodology: https://510kreport.com/methodology