# K980645: Philips Gyroscan NT Release 6 Series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: May 11, 1998 after 81 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). 1 ancestor in all.
4 later devices descend from it; 4 cite 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)
- K963990: Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series, Philips Medical Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- 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 Release 6 series have the same intended use as its predecessor and predicate device Gyroscan NT Release 5. The 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/K980645
Methodology: https://510kreport.com/methodology