# K962933: Opart MRT-600

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Oct 25, 1996 after 88 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
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Flexart™: named in the summary without a submission number
- (no number) Access™: named in the summary without a submission number

## Most influential descendants
- K981475: Opart (MRT-600) Versions 2 Software Upgrade (1998), 7 descendants of its own
- K990260: OPART (1999), 6 descendants of its own
- 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

## Indications for use
Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart Nuclei excited: Hydrogen Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

Source page: https://510kreport.com/device/K962933
Methodology: https://510kreport.com/methodology