# K032490: Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Aug 21, 2003 after 9 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002531 (2000). 2 ancestors in all.
73 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023511: Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2, Toshiba America Medical Systems, In.C (2002)

## Most influential descendants
- K060003: Excelart Vantage ZGV (2006), 69 descendants of its own
- K063361: Excelart Vantage Atlas, Model MRT-1503 (2006), 68 descendants of its own
- K080038: Vantage Titan, Model MRT-1504/S3 (2008), 61 descendants of its own
- K102489: Vantage Titan 3T (2011), 56 descendants of its own
- K113093: Vantage Titan 3T (2012), 53 descendants of its own

## Recalls of this device
- May 13, 2008 · Class II · Z-2278-2012: The status display in the sequence queue window may not change from "Current" to "Done".
- Oct 12, 2005 · Not classified · Z-0281-06: To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.
- Sep 16, 2004 · Not classified · Z-0061-05: Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.

## 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 Angiography / MR Vascular Imaging Blood Oxygenation Level Dependent (BOLD) imaging Perfusion / Diffusion Imaging Proton Spectroscopy

Source page: https://510kreport.com/device/K032490
Methodology: https://510kreport.com/methodology
