Cleared Traditional

ARGOS (K061479) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061479 · 3D Line Medical Systems S.R.L. · Neurology device
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Apr 2007
Decision
310d
Days
Class 2
Risk

K061479 is an FDA 510(k) clearance for the ARGOS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by 3D Line Medical Systems S.R.L. (Milan, IT). The FDA issued a Cleared decision on April 5, 2007 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all 3D Line Medical Systems S.R.L. devices

Submission Details

510(k) Number K061479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date April 05, 2007
Days to Decision 310 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 148d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 422
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