Cleared Traditional

K092308 - POLESTAR

K092308 is the FDA 510(k) clearance for POLESTAR by Medtronic Navigation Israel, Ltd.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K092308 · Medtronic Navigation Israel, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
229d
Days
Class 2
Risk

K092308 is an FDA 510(k) clearance for the POLESTAR, MODEL N-30. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medtronic Navigation Israel, Ltd. (Yokneam Elit, IL). The FDA issued a Cleared decision on March 16, 2010 after a review of 229 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Navigation Israel, Ltd. devices

Submission Details

510(k) Number K092308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2009
Decision Date March 16, 2010
Days to Decision 229 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 107d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 813
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K092308.
MAGNETOM AERA
K101347 · Siemens Medical Solutions USA, Inc. · Oct 2010
MR RADIATION ONCOLOGY OPTIONS
K102155 · Ge Medical Systems, LLC · Aug 2010
MRI PATIENT POSITIONING DEVICES
K093738 · Medtec, Inc. · May 2010
3D ASL
K092925 · Ge Medical Systems, LLC · Jan 2010
O-SCAN MR SYSTEM
K092469 · Esaote, S.P.A. · Dec 2009
MR-TOUCH OPTION
K083421 · Ge Medical Systems, LLC · Jul 2009