# K041112: Magnetom Espree System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 21, 2004 after 84 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971684 (1997). 3 ancestors in all.
422 later devices descend from it; 5 cite it directly.
22 of 426 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.

## Most influential descendants
- K052164: Magnetom Systems with Software Syngo MR 2006A (2005), 312 descendants of its own
- 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

## Recalls of this device
- Mar 3, 2011 · Not classified · Z-2021-2011: Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to beco
- Nov 5, 2007 · Not classified · Z-0518-2008: Table may experience a deadlock situation
- Mar 30, 2007 · Not classified · Z-0769-2007: If table top is not seated properly it can lock up/stick.
- Aug 12, 2005 · Not classified · Z-1529-05: there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

## Indications for use
The MAGNETOM Espree is 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. The MAGNETOM Espree 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/K041112
Methodology: https://510kreport.com/methodology