POLESTAR N-20
FDA 510(k) clearance K032541 · decided 2003-09-12
Clearance details
- K-number
- K032541
- Device name
- POLESTAR N-20
- Applicant
- Odin Medical Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-18
- Decision date
- 2003-09-12
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yokneam Elit, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, T recall (Z-2129-2016) | Medtronic Navigation | 2016-07-06 |
| PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063, Usage: Low field MRI de recall (Z-2240-2010) | Odin Medical Technologies Ltd. | 2010-08-19 |