# K972990: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Feb 5, 1998 after 177 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 K971055 (1997). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971055: Diffusion Weighted MR Imaging /Magnetom Vision, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K031230: GE Propeller Imaging Option for Mri (2003), 3 descendants of its own
- K113394: Mavric SL (2012), 1 descendant of its own
- K143253: O-MAR (2015), 0 descendants of its own
- K073081: Jet Software for Excelart Vantage Atlas-Z and Atlas-X (2007), 0 descendants of its own

## Indications for use
Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke. Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.

Source page: https://510kreport.com/device/K972990
Methodology: https://510kreport.com/methodology