Cleared Special

K990326 - OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII

K990326 is an FDA 510(k) clearance for OPTICAL TRACKING SYSTEM MICROSCOPE MODU..., manufactured by Radionics Software Applications, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 30-day FDA review.

K990326 · Radionics Software Applications, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
30d
Days
Class 2
Risk

K990326 is an FDA 510(k) clearance for the OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII. 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 March 4, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990326

510(k) Number K990326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1999
Decision Date March 04, 1999
Days to Decision 30 days
Submission Type Special
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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 408
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K990326.
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
K990214 · Surgical Navigation Technologies, Inc. · Apr 1999
VIEWPOINT MICROSCOPE OPTION
K990860 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
VIEWPOINT PASSIVE TOOL OPTION
K990868 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
TRAJECTORY GUIDE, MODEL # TGX-XXX
K983539 · Image-Guided Neurologics, Inc. · Feb 1999
PHILIPS EASYGUIDE
K981480 · Philips Medical Systems, Inc. · Jan 1999
STEALTHSTATION SYSTEM
K983670 · Surgical Navigation Technologies, Inc. · Jan 1999
K990326 · OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
Download PDF FDA Summary Radionics Software Ap…