# K092308: Polestar, Model N-30

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation Israel, Ltd.
- Decided: Mar 16, 2010 after 229 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010850 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032541: Polestar N-20, Odin Medical Technologies, Ltd. (2003) Summary page 2.

## Recalls of this device
- Jun 20, 2016 · Class II · Z-2129-2016: Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.

## Indications for use
The PoleStar N-30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of the head selected by the physician. The images produced by the PoleStar N-30 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2) and T2*. Anatomical regions: sections of the head selected by the physician. Nuclei excited: H-1 Diagnostic uses: TI, T2, T2* and density weighted imaging. The PoleStar N-30 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K092308
Methodology: https://510kreport.com/methodology