# K970573: Flexart V3.5 Software

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Jul 21, 1997 after 157 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 K933018 (1994). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962138: Flexart V3.1 Software, Toshiba America Mri, Inc. (1996) Summary page 2.

## Most influential descendants
- K983110: Flexart,Flexart/Hyper, Visart, Visart/Hyper (1999), 2 descendants of its own
- K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon (2000), 1 descendant of its own
- K080119: Clearscan (2008), 0 descendants 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, joints, spine, neck, TMJ, heart, blood vessels, and breast). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, 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/K970573
Methodology: https://510kreport.com/methodology