# K113093: Vantage Titan 3T

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 13, 2012 after 86 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002531 (2000). 7 ancestors in all.
53 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102489: Vantage Titan 3T, Toshiba Medical Systems Corporation, Japan (2011) Summary page 1.

## Most influential descendants
- K120487: Vantage Titan 3T (2012), 52 descendants of its own
- K132160: Vantage Titan 3T (2013), 37 descendants of its own
- K143008: Vantage Titan 3T (2015), 36 descendants of its own
- K152371: Vantage Titan 3T (2015), 32 descendants of its own
- K162183: Vantage Galan 3T, MRT-3020, V4.0 (2016), 31 descendants of its own

## Recalls of this device
- Oct 15, 2012 · Class II · Z-1101-2013: It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system

## Indications for use
Vantage Titan 3T systems are 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. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear resonance (NMR). The NMR properties of body tissues and fluids are: *Proton density (PD) (also called hydrogen density) *Spin-lattice relaxation time (TI) *Spin-spin relaxation time JT2) *Flow dynamics *Ghemical shift Contrast agent use us 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/K113093
Methodology: https://510kreport.com/methodology