Cleared Traditional

K172820 - Microscope Navigation Software (FDA 510(k) Clearance)

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

K172820 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
164d
Days
Class 2
Risk

K172820 is an FDA 510(k) clearance for the Microscope Navigation Software. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on March 1, 2018 after a review of 164 days - an extended review cycle.

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. Standard predicate reliance. 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 Brainlab AG devices

Submission Details

510(k) Number K172820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date March 01, 2018
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 148d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K172820.
Zeta Navigation System
K253663 · Zeta Surgical, Inc. · May 2026
Stealth AXiS Cranial clinical application
K253379 · Medtronic Navigation, Inc. · Mar 2026
NeuroAlign software
K231897 · Medivis, Inc. · Oct 2025
SOLOPASS 2.0 System
K251317 · Intravent Medical Partners · Sep 2025
Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025