# K963990: Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: May 29, 1997 after 237 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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 no predicate by number.

## Most influential descendants
- K980645: Philips Gyroscan NT Release 6 Series (1998), 4 descendants of its own
- K992533: Philips Gyroscan Intera (*) (1999), 0 descendants of its own
- K992892: Stepping Kinematic Imaging Platform (Skip) (1999), 0 descendants of its own
- K991765: Synergy Shoulder Coil (1999), 0 descendants of its own
- K982834: Restgrid Package/Gyroscan NT (1998), 0 descendants of its own

## Indications for use
The Philips Gyroscan NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and *'P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K963990
Methodology: https://510kreport.com/methodology
