Cleared Traditional

K963221 - OPTICAL DIGITIZER OPTION FOR VIEW POINT

K963221 is an FDA 510(k) clearance for OPTICAL DIGITIZER OPTION FOR VIEW POINT, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K963221

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.

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 341
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K963221.
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc. · May 1997
NEUROMATE STEREOTACTIC SYSTEM
K963256 · Integrated Surgical Systems, S.A. · 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
STEALTHSTATION SYSTEM
K963173 · Surgical Navigation Technologies, Inc. · Oct 1996
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
K961844 · Radionics Software Applications, Inc. · Oct 1996