# K990260: OPART

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Apr 15, 1999 after 78 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 K962933 (1996). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981475: Opart (MRT-600) Versions 2 Software Upgrade, Toshiba America Mri, Inc. (1998) Summary page 2.

## Most influential descendants
- K151466: MrOpen (2015), 3 descendants of its own
- K190524: MRopen 0.5 T (2019), 2 descendants of its own
- K193116: MRopen EVO (2019), 1 descendant of its own
- K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon (2000), 1 descendant of its own
- K242258: MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (2024), 0 descendants of its own

## Indications for use
Imaging of: The Whole Body (including head, abdomen, breast, 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

Source page: https://510kreport.com/device/K990260
Methodology: https://510kreport.com/methodology