# K122613: Vantage Titan with Helios Gradient Model MRT-1504/US

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 13, 2012 after 108 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K002531 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120638: Vantage Titan, Toshibamedical Systems Corporation (2012) Summary page 2.
- K112003: Vantage Titan HSR, Toshibamedical Systems Corporation (2011) Summary page 2.

## Recalls of this device
- May 10, 2024 · Class II · Z-2041-2024: The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followe
- Jan 29, 2024 · Class II · Z-1250-2024: For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values descri
- May 21, 2021 · Class II · Z-2044-2021: The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

## Indications for use
The MRI system is indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are: - Proton density (PD) (also called hydrogen density), - Spin-lattice relaxation time (Ti1), - Spin-spih relaxation time (T2), - Flow dynamics, - Chemical shift. Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Source page: https://510kreport.com/device/K122613
Methodology: https://510kreport.com/methodology