# K060003: Excelart Vantage ZGV

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 18, 2006 after 15 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: 3 generations back to K002531 (2000). 3 ancestors in all.
69 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032490: Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2, Toshiba America Medical Systems, In.C (2003) Summary page 2.

## Most influential descendants
- 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
- K120487: Vantage Titan 3T (2012), 52 descendants of its own

## Recalls of this device
- Feb 21, 2012 · Class II · Z-2315-2012: The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.

## 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 ScanCine 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/K060003
Methodology: https://510kreport.com/methodology