# K961842: Software Version 8.5CD of the MRT-35A Magnetic Resonance Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Aug 2, 1996 after 81 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.
No later device cites it as a predicate yet.
0 of 1 device 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) 8.0CD Software release for MRT-35A: named in the summary without a submission number

## Indications for use
Anatomical Region: Head, body, extremity, spine, neck, TMJ, Knee Nuclei excited: Hydrogen Diagnostic Use: 2D and 3D imaging, Contrast Media, MR Vascular Imaging

Source page: https://510kreport.com/device/K961842
Methodology: https://510kreport.com/methodology