# K032541: Polestar N-20

- Pathway: 510(k) (Special)
- Applicant: Odin Medical Technologies, Ltd.
- Decided: Sep 12, 2003 after 25 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010850 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010850: Polestar N-10, Odin Medical Technologies, Ltd. (2001) Summary page 4.

## Most influential descendants
- K092308: Polestar, Model N-30 (2010), 0 descendants of its own

## 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.
- Jul 1, 2010 · Not classified · Z-2240-2010: Electronic box on headstrap may overheat, causing burn to patient.

## Indications for use
The Polestar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the Polestar N-20 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 (Tl), spin-spin relaxation time (T2) and T2*. Anatomical regions: extremities and selected sections of the head. Nuclei excited: H- 1 Diagnostic uses: T1, T2, T2* and density weighted imaging. The Polestar N-20 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/K032541
Methodology: https://510kreport.com/methodology