# K152371: Vantage Titan 3T

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Oct 23, 2015 after 63 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: 11 generations back to K002531 (2000). 11 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143008: Vantage Titan 3T, Toshibamedical Systems Corporation (2015) Summary page 5.

## Most influential descendants
- K162183: Vantage Galan 3T, MRT-3020, V4.0 (2016), 31 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
- K173382: Vantage Galan 3T, V4.6 (2018), 13 descendants of its own
- K193021: Vantage Orian 1.5T, MRT-1550, V6.0 (2020), 12 descendants of its own

## Recalls of this device
- Apr 14, 2016 · Class II · Z-2135-2016: A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI 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 magnetic resonance (NMR). The NMR properties of body tissues and fluids are: • Proton density (PD) (also called hydrogen density) • Spin-lattice relaxation time (T1) • 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/K152371
Methodology: https://510kreport.com/methodology