# K964608: MRT-35A V9.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Feb 4, 1997 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: 1 generation back to K933018 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945798: MRT-35A Upgrade 8.0CD, Toshiba America Mri, Inc. (1995) Summary page 2.
- K933018: MRT-50GP, Toshiba America Mri, Inc. (1994) Summary page 2.

## Indications for use
1. Anatomical region: Head, Body, Spine, Neck, TMJ, and Heart 2. Nuclei excited: Hydrogen 3. Diagnostic Uses: 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/K964608
Methodology: https://510kreport.com/methodology