# K964778: HI-Star Mri Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Health Images, Inc.
- Decided: Feb 24, 1997 after 89 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Health Images Hi-Standard 0.6T whole body MRI imager, superconducting magnet: named in the summary without a submission number
- (no number) Health Images HI-Standard/Calibre 0.6T whole body MRI imager, IRIS sequence superconducting magnet, IRIS Silicone Specific Sequence: named in the summary without a submission number
- (no number) Health Images HI STAR - 0.6T whole body MRI imager, superconducting magnet: named in the summary without a submission number
- (no number) Elscint Gyrex 2T Prestige Spectral Fat Suppression, FSE: named in the summary without a submission number
- (no number) Philips Gyroscan NT, 1T Spectral Fat Suppression: named in the summary without a submission number

## Indications for use
The HI STAR system is indicated for use a general purpose MR imager that produces transverse, sagittal, coronal, and oblique cross-sectional images of internal structures of the human body, head, and extremities. Contrast in these images reflect the intrinsic properties of the hydrogen proton, proton density, T1, and T2, and the extrinsic parameters of the applied imaging sequences. The indications for the HI STAR do not differ significantly from the predicate, or legally marketed devices.

Source page: https://510kreport.com/device/K964778
Methodology: https://510kreport.com/methodology