Cleared Special

K983669 - OPTICAL TRACKING SYSTEM WITH SURFACE MA...

K983669 is the FDA 510(k) clearance for OPTICAL TRACKING SYSTEM WITH SURFACE MA... by Radionics, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 30-day FDA review.

K983669 · Radionics, Inc. · Neurology device
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Nov 1998
Decision
30d
Days
Class 2
Risk

K983669 is an FDA 510(k) clearance for the OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on November 18, 1998 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.

View all Radionics, Inc. devices

Submission Details

510(k) Number K983669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date November 18, 1998
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 225
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K983669.
VIEWPOINT PASSIVE TOOL OPTION
K990868 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
PHILIPS EASYGUIDE
K981480 · Philips Medical Systems, Inc. · Jan 1999
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
K984245 · Radionics, Inc. · Dec 1998
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · Radionics, Inc. · Nov 1998
VECTORVISION SPINE MODULE
K981508 · Brainlab AG · Oct 1998
PHILIPS EASYGUIDE
K980820 · Philips Medical Systems, Inc. · Oct 1998