510(k) · Cleared
Recalled · Class II · 2016Polestar, Model N-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation Israel, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 16, 2010 as substantially equivalent to K032541 (Odin Medical Technologies, Ltd., 2003) after a 229-day review. Its family tree reaches back 2 generations to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Mar 16, 2010
- Review
- 229 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010850 (2001). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK010850 Polestar N-10Odin Medical Technologies, Ltd. · 2001 · Recalled (Class I)
- 1 generation backK032541 Polestar N-20Odin Medical Technologies, Ltd. · 2003 · Recalled
- This deviceK092308 Polestar, Model N-30Medtronic Navigation Israel, Ltd. · 2010
Class I recalls in this family
- K010850 Polestar N-102 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032541 | Polestar N-20Summary page 2…cant Name 51 0(k) Classification Device Name Number PoleStar N-20 ODIN Technologies Ltd. K032541_}Class 11device Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Ta… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2016 | Class II | Z-2129-2016 | Process change control | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K010850Polestar N-10Odin Medical Technologies, Ltd. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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…
Read the full statement (123 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092308 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092308: Polestar, Model N-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092308
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026