Cleared Traditional

K013419 - NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

K013419 is an FDA 510(k) clearance for NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM, manufactured by Nicolet Biomedical. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K013419 · Nicolet Biomedical · Radiology device
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Dec 2001
Decision
66d
Days
Class 2
Risk

K013419 is an FDA 510(k) clearance for the NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Nicolet Biomedical (Golden, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Nicolet Biomedical devices

FDA 510(k) Submission Details - K013419

510(k) Number K013419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 20, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1152
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K013419.
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