# K002531: Excelart with Pianissimo, Model MRT-1501/P3

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Oct 26, 2000 after 71 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
76 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023511: Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 (2002), 74 descendants of its own
- K032490: Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2 (2003), 73 descendants of its own
- 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

## Recalls of this device
- May 25, 2005 · Not classified · Z-0986-05: Patient information A is displayed with images for patient B.
- Oct 6, 2004 · Not classified · Z-0270-05: Software defect causes images to be rotated 180 degrees.
- Jun 7, 2004 · Not classified · Z-1045-04: Wrong positioning may cause patient burns.
- May 6, 2004 · Not classified · Z-0937-04: Software anomaly.

Source page: https://510kreport.com/device/K002531
Methodology: https://510kreport.com/methodology