# K032428: Magnetom Avanto MR System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 16, 2003 after 79 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: 1 generation back to K971684 (1997). 2 ancestors in all.
431 later devices descend from it; 11 cite it directly.
22 of 434 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993731: Sonata Gradients/Magnetom Symphony System, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 2.

## Most influential descendants
- K050200: Magnetom Trio a Tim System (2005), 428 descendants of its own
- K050199: Magnetom Symphony a Tim System (2005), 422 descendants of its own
- K041112: Magnetom Espree System (2004), 422 descendants of its own
- 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

## Recalls of this device
- Dec 7, 2015 · Class II · Z-0467-2016: Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench 
- 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
- Aug 12, 2005 · Not classified · Z-1528-05: there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
- Jul 28, 2004 · Not classified · Z-1395-04: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

## Indications for use
The MAGNETOM Avanto is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images andor spectra, and that display the internal structure and/or function of the head, body, or extremities. These images andor spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Avanto 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/K032428
Methodology: https://510kreport.com/methodology