# K013586: Magnetom Trio System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Dec 28, 2001 after 59 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.
436 later devices descend from it; 3 cite it directly.
22 of 437 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 3.0 T Allegra Dedicated Head only System: named in the summary without a submission number
- (no number) GE’s Body Imaging Coil for 3.0T Signa VH /1 system: named in the summary without a submission number
- (no number) MAGNETOM 1.5 T Sonata System: named in the summary without a submission number
- (no number) 3.0 T Dedicated Head Only Allegra System: named in the summary without a submission number

## Most influential descendants
- K050200: Magnetom Trio a Tim System (2005), 428 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
- K072237: Magnetom Verio (2007), 300 descendants of its own
- K082427: Syngo MR B17 (2008), 229 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
- Jul 28, 2004 · Not classified · Z-1403-04: 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-1404-04: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Dec 18, 2003 · Not classified · Z-0521-04: tissue roll can become magnetic

## Indications for use
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system 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 echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Source page: https://510kreport.com/device/K013586
Methodology: https://510kreport.com/methodology