# K965068: Magnetic Resonanc Dvce Visart V 3.5 Software

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jul 15, 1997 after 209 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903768 (1990). 2 ancestors in all.
5 later devices descend from it; 3 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)
- K961092: Visart, Toshiba America Medical Systems, In.C (1996) Summary page 1.

## Most influential descendants
- 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
- K023207: Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit) (2002), 0 descendants of its own

## Indications for use
Imaging of: - The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels and breast). [Application terms include MR Fluoroscopy, MR Urography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] - Fluid Visualization - 2D/3D Imaging - MR Angiography/MR Vascular Imaging

Source page: https://510kreport.com/device/K965068
Methodology: https://510kreport.com/methodology