Cleared Traditional

K963221 - OPTICAL DIGITIZER OPTION FOR VIEW POINT

K963221 is the FDA 510(k) clearance for OPTICAL DIGITIZER OPTION FOR VIEW POINT by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K963221 · Philips Medical Systems (Cleveland), Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
147d
Days
Class 2
Risk

K963221 is an FDA 510(k) clearance for the OPTICAL DIGITIZER OPTION FOR VIEW POINT. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 147 days - within the typical 510(k) review window.

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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K963221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1996
Decision Date January 10, 1997
Days to Decision 147 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
1d faster than avg
Panel avg: 148d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K963221.
LEKSELL STEREOTACTIC SYSTEM
K972324 · Elekta Instrument AB · Mar 1998
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc. · May 1997
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K965139 · Carl Zeiss, Inc. · Apr 1997
PHILIPS EASYGUIDE NEURO
K961834 · Philips Medical Systems, Inc. · Nov 1996
BRAINLAB HEADPINS
K954789 · Brainlab AG · Aug 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961858 · Radionics, Inc. · Aug 1996