Cleared Special

K984245 - NON-INVASIVE DYNAMIC REFERENCE FRAME (D...

K984245 is the FDA 510(k) clearance for NON-INVASIVE DYNAMIC REFERENCE FRAME (D... by Radionics, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 21-day FDA review.

K984245 · Radionics, Inc. · Neurology device
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Dec 1998
Decision
21d
Days
Class 2
Risk

K984245 is an FDA 510(k) clearance for the NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL.... 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 December 18, 1998 after a review of 21 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 K984245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1998
Decision Date December 18, 1998
Days to Decision 21 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
127d faster than avg
Panel avg: 148d · This submission: 21d
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 K984245.
VIEWPOINT MICROSCOPE OPTION
K990860 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
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PHILIPS EASYGUIDE
K981480 · Philips Medical Systems, Inc. · Jan 1999
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983669 · Radionics, Inc. · Nov 1998
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · Radionics, Inc. · Nov 1998
VECTORVISION SPINE MODULE
K981508 · Brainlab AG · Oct 1998