Cleared Traditional

K993673 - SNN FLUORO NAVIGATION SYSTEM

K993673 is an FDA 510(k) clearance for SNN FLUORO NAVIGATION SYSTEM, manufactured by I.S.G. Technologies, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K993673 · I.S.G. Technologies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
50d
Days
Class 2
Risk

K993673 is an FDA 510(k) clearance for the SNN FLUORO NAVIGATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on December 21, 1999 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K993673

510(k) Number K993673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date December 21, 1999
Days to Decision 50 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
99d faster than avg
Panel avg: 149d · This submission: 50d
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 408
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K993673.
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · Stryker Corp. · Jan 2000
BRAINLAB STEREOTACTIC ARC
K992916 · Brainlab · Jan 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992927 · Surgical Navigation Technologies, Inc. · Dec 1999
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · Stryker Corp. · Dec 1999
3D1 MICROPOSITIONING HEADSTAGE
K993501 · Scientific Tools, Inc. · Nov 1999
AXON MP-1 MICROPOSITIONER
K990683 · Axon Instruments, Inc. · Nov 1999
K993673 · SNN FLUORO NAVIGATION SYSTEM
Download PDF FDA Summary I.S.G. Technologies, …