# K973658: Diffusion Package / Gyroscan NT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: May 6, 1998 after 223 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 K963990 (1997). 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)
- K963990: Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series, Philips Medical Systems, Inc. (1997) Summary page 1.
- K971055: Diffusion Weighted MR Imaging /Magnetom Vision, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Indications for use
Diffusion Weighted Imaging is intended for use in generating unique contrast/information about the diffuse mobility of water or other proton containing molecules. Changes in mobility of the apparent diffusion coefficients in tissue can be seen much earlier phase than originally possible with conventional proton density, T1 or T2 weighted imaging. This change indicates neurological anomalies, of which diagnosis of acute stroke is one of the important applications. Diffusion Weighted Imaging generates contrast/information about the apparent diffusion coefficients that reflect the anisotropic nature of tissue composition (e.g. fiber tracts in brain white matter) that otherwise cannot be visualized by conventional proton density, Tl or T2 weighted imaging.

Source page: https://510kreport.com/device/K973658
Methodology: https://510kreport.com/methodology