# K962138: Flexart V3.1 Software

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Dec 23, 1996 after 203 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: 1 generation back to K933018 (1994). 1 ancestor in all.
5 later devices descend from it; 3 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)
- K933018: MRT-50GP, Toshiba America Mri, Inc. (1994) Summary page 2.

## Most influential descendants
- K970573: Flexart V3.5 Software (1997), 4 descendants of its own
- 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
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/K962138
Methodology: https://510kreport.com/methodology