# K974530: Duffusion-Weighted MR Imaging Package

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 6, 1998 after 66 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: 2 generations back to K931544 (1993). 4 ancestors in all.
1 later device descends 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)
- K954646: Epi-II System Option W/High Performance Gradients, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.
- K971055: Diffusion Weighted MR Imaging /Magnetom Vision, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.

## Most influential descendants
- K980831: Image Post-Processing Techniques (1998), 0 descendants of its own

## Indications for use
The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of 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/K974530
Methodology: https://510kreport.com/methodology