# K990007: Opart, Model MRT-600

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Apr 1, 1999 after 87 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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: 3 generations back to K893619 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964753: Matrix 3000 Flexible Spine Coil, Us Asia Instruments, Inc. (1997) Summary page 2.

## 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/K990007
Methodology: https://510kreport.com/methodology