# K993731: Sonata Gradients/Magnetom Symphony System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 23, 1999 after 49 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
No predicates in its family tree.
440 later devices descend from it; 4 cite it directly.
22 of 441 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MAGNETOM Symphony System: named in the summary without a submission number

## Most influential descendants
- K032428: Magnetom Avanto MR System (2003), 431 descendants of its own
- 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

## Recalls of this device
- Mar 31, 2011 · Not classified · Z-2786-2011: Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.
- Jul 28, 2004 · Not classified · Z-1401-04: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Jul 28, 2004 · Not classified · Z-1402-04: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Jul 28, 2004 · Not classified · Z-1400-04: 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 SYMPHONY with the Sonata Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the Sonata Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the Sonata Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K993731
Methodology: https://510kreport.com/methodology