# K992533: Philips Gyroscan Intera (*)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Oct 18, 1999 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: 2 generations 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)
- K980645: Philips Gyroscan NT Release 6 Series, Philips Medical Systems North America, Inc. (1998) Summary page 1.

## Indications for use
The Philips Gyroscan INTERA (Release 7) series are indicated for use as magnetic resonance diagnostic devices (MRDD’s) that produce transverse, sagittal, coronal and obhque 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/K992533
Methodology: https://510kreport.com/methodology