Cleared Traditional

K983764 - VIEWPOINT TOOLS- STERRAD

K983764 is the FDA 510(k) clearance for VIEWPOINT TOOLS- STERRAD 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 255-day FDA review.

K983764 · Philips Medical Systems (Cleveland), Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
255d
Days
Class 2
Risk

K983764 is an FDA 510(k) clearance for the VIEWPOINT TOOLS- STERRAD. 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 July 8, 1999 after a review of 255 days - an extended review cycle.

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 K983764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date July 08, 1999
Days to Decision 255 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
107d slower than avg
Panel avg: 148d · This submission: 255d
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 K983764.
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K983831 · Brainlab AG · May 1999
OPTICAL TRACKING SYSTEM (OTS)
K990632 · Radionics, Inc. · Apr 1999
VIEWPOINT MICROSCOPE OPTION
K990860 · Philips Medical Systems (Cleveland), Inc. · Mar 1999