# K961092: Visart

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 14, 1996 after 87 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: 1 generation back to K903768 (1990). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903768: Magnetic Resonance Device MRT 150A, Toshiba America Mri, Inc. (1990) Summary page 2.

## Most influential descendants
- K965068: Magnetic Resonanc Dvce Visart V 3.5 Software (1997), 5 descendants of its own
- K990620: Excelart (1999), 2 descendants of its own
- K983110: Flexart,Flexart/Hyper, Visart, Visart/Hyper (1999), 2 descendants of its own
- K993803: Excelart with Pianissimo (2000), 1 descendant of its own
- K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon (2000), 1 descendant 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
Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart Nuclei excited: Hydrogen Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

Source page: https://510kreport.com/device/K961092
Methodology: https://510kreport.com/methodology