# K102489: Vantage Titan 3T

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba Medical Systems Corporation, Japan
- Decided: Aug 2, 2011 after 336 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: 6 generations back to K002531 (2000). 6 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 63 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.

## Most influential descendants
- K113093: Vantage Titan 3T (2012), 53 descendants of its own
- 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

## Recalls of this device
- Oct 28, 2013 · Class II · Z-0201-2014: Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination 

## Indications for use
Vantage Titan ST 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 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 (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/K102489
Methodology: https://510kreport.com/methodology