Cleared Traditional

K964801 - OPTICAL TRACKING SYSTEM (OTS)

K964801 is an FDA 510(k) clearance for OPTICAL TRACKING SYSTEM (OTS), manufactured by Radionics Software Applications, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K964801 · Radionics Software Applications, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
185d
Days
Class 2
Risk

K964801 is an FDA 510(k) clearance for the OPTICAL TRACKING SYSTEM (OTS). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Radionics Software Applications, Inc. (Burlington, US). The FDA issued a Cleared decision on June 2, 1997 after a review of 185 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 Radionics Software Applications, Inc. devices

FDA 510(k) Submission Details - K964801

510(k) Number K964801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date June 02, 1997
Days to Decision 185 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 148d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 277
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K964801.
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K963221 · Philips Medical Systems (Cleveland), Inc. · Jan 1997