# K023207: Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 9, 2002 after 14 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: 5 generations back to K903768 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon, Toshiba America Mri, Inc. (2000) Summary page 1.
- K993803: Excelart with Pianissimo, Toshiba America Mri, Inc. (2000) Summary page 3.
- K002531: Excelart with Pianissimo, Model MRT-1501/P3, Toshiba America Mri, Inc. (2000)
- (no number) EXCELART FM with Pianissimo: named in the summary without a submission number

## 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 MR Angiography / MR Vascular Imaging Water / Fat Imaging Perfusion / Diffusion Imaging

Source page: https://510kreport.com/device/K023207
Methodology: https://510kreport.com/methodology