# K991057: Extra Large Body Coil for Opart (MRT-600)

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: May 20, 1999 after 51 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: 1 generation back to K962933 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962933: Opart MRT-600, Toshiba America Mri, Inc. (1996) Summary page 1.

## 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/K991057
Methodology: https://510kreport.com/methodology