# K080038: Vantage Titan, Model MRT-1504/S3

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jan 22, 2008 after 15 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: 5 generations back to K002531 (2000). 5 ancestors in all.
61 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063361: Excelart Vantage Atlas, Model MRT-1503, Toshiba America Medical Systems, In.C (2006) Summary page 1.

## Most influential descendants
- K102489: Vantage Titan 3T (2011), 56 descendants of its own
- 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

## Recalls of this device
- Apr 13, 2020 · Class II · Z-2245-2020: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
- May 13, 2008 · Class II · Z-2278-2012: The status display in the sequence queue window may not change from "Current" to "Done".

## Indications for use
Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] Fluid Visualization 2D / 3D Imaging MR Angiographl) / MR Vascular Imaging Blood Oxygenation Level Dependent (BOLD) imaging Perfusion / Diffusion Imaging Proton Spectroscopy

Source page: https://510kreport.com/device/K080038
Methodology: https://510kreport.com/methodology