Cleared Special

K000310 - VOYAGER 6.0 SOFTWARE OPTION

K000310 is the FDA 510(k) clearance for VOYAGER 6.0 SOFTWARE OPTION by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 14-day FDA review.

K000310 · Philips Medical Systems (Cleveland), Inc. · Neurology device
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Feb 2000
Decision
14d
Days
Class 2
Risk

K000310 is an FDA 510(k) clearance for the VOYAGER 6.0 SOFTWARE OPTION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on February 15, 2000 after a review of 14 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K000310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2000
Decision Date February 15, 2000
Days to Decision 14 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
134d faster than avg
Panel avg: 148d · This submission: 14d
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 K000310.
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · Radionics, Inc. · May 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · Stryker Corp. · Jan 2000
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · Stryker Corp. · Dec 1999
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · Philips Medical Systems (Cleveland), Inc. · Oct 1999