Cleared Traditional

K061479 - ARGOS

K061479 is an FDA 510(k) clearance for ARGOS, manufactured by 3D Line Medical Systems S.R.L.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K061479 · 3D Line Medical Systems S.R.L. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K061479

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.

HAW Device Classification - Class 2, Special Controls

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 298
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