# K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Jan 18, 2000 after 89 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: 4 generations back to K903768 (1990). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990260: OPART, Toshiba America Mri, Inc. (1999) Summary page 1.
- K983110: Flexart,Flexart/Hyper, Visart, Visart/Hyper, Toshiba America Mri, Inc. (1999) Summary page 3.
- K962933: Opart MRT-600, Toshiba America Mri, Inc. (1996) Summary page 3.
- K962138: Flexart V3.1 Software, Toshiba America Mri, Inc. (1996) Summary page 3.
- K946244: Access (TM) Compass Bed, Toshiba America Mri, Inc. (1995) Summary page 3.
- K933018: MRT-50GP, Toshiba America Mri, Inc. (1994) Summary page 3.

## Most influential descendants
- 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). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] - Fluid Visualization - 2D/3D Imaging Additional indications for v3.1, v3.2, & v3.3 (only) - MR Angiography/MR Vascular Imaging Additional indication for v3.2 & v3.3 (only) - Water/Fat Imaging Additional indication for v3.3 (only) - Perfusion/Diffusion Imaging

Source page: https://510kreport.com/device/K993574
Methodology: https://510kreport.com/methodology