Cleared Traditional

K983764 - VIEWPOINT TOOLS- STERRAD

K983764 is an FDA 510(k) clearance for VIEWPOINT TOOLS- STERRAD, 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 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

FDA 510(k) Submission Details - K983764

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.

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 K983764.
REMOTE INTRODUCER, MODEL PI-1000
K990907 · Image-Guided Neurologics, Inc. · Aug 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · Elekta Instrument AB · Jul 1999
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
K991267 · Ohio Medical Instrument Co., Inc. · Jul 1999
FRAMELESS NEUROMATE
K991081 · Integrated Surgical Systems, Inc. · Jun 1999
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
K984298 · Z-Kat, Inc. · Jun 1999
VECTORVISION2
K983831 · Brainlab AG · May 1999