# K990620: Excelart

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: May 14, 1999 after 78 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903768 (1990). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965068: Magnetic Resonanc Dvce Visart V 3.5 Software, Toshiba America Medical Systems, In.C (1997) Summary page 1.

## Most influential descendants
- K993803: Excelart with Pianissimo (2000), 1 descendant of its own
- K023207: Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit) (2002), 0 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.
- Jan 27, 2004 · Not classified · Z-0546-04: Software anomally causes image slices to be in incorrect order.

## Indications for use
Imaging of: The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), 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

Source page: https://510kreport.com/device/K990620
Methodology: https://510kreport.com/methodology