# K982834: Restgrid Package/Gyroscan NT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Oct 29, 1998 after 78 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 K900889 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980645: Philips Gyroscan NT Release 6 Series, Philips Medical Systems North America, Inc. (1998) Summary page 2.
- K973799: Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Indications for use
The RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems. This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study. The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 3'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/K982834
Methodology: https://510kreport.com/methodology