Cleared Traditional

K002242 - POLESTAR N-10

K002242 is an FDA 510(k) clearance for POLESTAR N-10, manufactured by Odin Technologies , Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K002242 · Odin Technologies , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
58d
Days
Class 2
Risk

K002242 is an FDA 510(k) clearance for the POLESTAR N-10. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Odin Technologies , Ltd. (Yokneam Elit, IL). The FDA issued a Cleared decision on September 20, 2000 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Odin Technologies , Ltd. devices

FDA 510(k) Submission Details - K002242

510(k) Number K002242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date September 20, 2000
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 957
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K002242.
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
K002531 · Toshiba America Mri, Inc. · Oct 2000
HITACHI ALTAIRE
K002420 · Hitachi Medical Systems America, Inc. · Oct 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · Siemens Medical Solutions USA, Inc. · Oct 2000
GYROSCAN INTERA (R7.5)
K001796 · Philips Medical Systems North America, Inc. · Sep 2000
EXPLORER GRADIENT
K001987 · Philips Medical Systems North America, Inc. · Sep 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283 · Medis Medical Imaging Systems BV · Aug 2000