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Polestar N-20

by Odin Medical Technologies, Ltd.

510(k) K032541

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK032541 Date12 Sep 2003ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2129-2016 FDA Class II initiated 20 Jun 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.

    • Terminated Z-2240-2010 FDA Unclassified (pre-2012) initiated 1 Jul 2010

    Electronic box on headstrap may overheat, causing burn to patient.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
FDA applicant
Odin Medical Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Polestar N-20 is a nuclear magnetic resonance imaging system designed to function as a magnetic resonance diagnostic device. It is used to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head by detecting the spatial distribution of protons exhibiting magnetic resonance.

This low-field MRI device is manufactured by Odin Medical Technologies, Ltd. and has received FDA 510(k) authorization. It is classified under regulation number 892.1000 within the radiology medical specialty.

Other devices from Odin Medical Technologies, Ltd.