# K971055: Diffusion Weighted MR Imaging /Magnetom Vision

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 20, 1997 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 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) Echo Planar Sequences: named in the summary without a submission number

## Most influential descendants
- K972990: Magnetic Resonance Diagnostic System (1998), 4 descendants of its own
- K031230: GE Propeller Imaging Option for Mri (2003), 3 descendants of its own
- K113394: Mavric SL (2012), 1 descendant of its own
- K974530: Duffusion-Weighted MR Imaging Package (1998), 1 descendant of its own
- K143253: O-MAR (2015), 0 descendants of its own

## Indications for use
The Siemens Diffusion-Weighted MR Imaging Package has been designed to image the djffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility by water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity. Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.

Source page: https://510kreport.com/device/K971055
Methodology: https://510kreport.com/methodology