# K120638: Vantage Titan

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jun 1, 2012 after 92 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (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.
21 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080038: Vantage Titan, Model MRT-1504/S3, Toshiba America Medical Systems, In.C (2008) Summary page 1.
- K112003: Vantage Titan HSR, Toshibamedical Systems Corporation (2011) Summary page 2.

## Most influential descendants
- K141472: Vantage Elan (2014), 19 descendants of its own
- K150427: Vantage Titan 1.5T, V3.1, MRT-1510 (2015), 18 descendants of its own
- K160632: Vantage Titan 1.5T, MRT-1510, V3.6 Software (2016), 17 descendants of its own
- K170412: Vantage Titan 1.5T, MRT-1510, M-Power GX (2017), 16 descendants of its own
- K182282: Vantage Orian 1.5T, MRT-1550, V4.5 (2018), 14 descendants of its own

## Recalls of this device
- May 30, 2018 · Class II · Z-0199-2019: When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual a
- 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
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 (Ti) - Spin-spin relaxation time JT2) - 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/K120638
Methodology: https://510kreport.com/methodology