Cleared Traditional

K901883 - STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE

K901883 is an FDA 510(k) clearance for STEREOTACTIC ONE MEDICAL APPLICATION SO..., manufactured by Stereotactic Image Systems, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K901883 · Stereotactic Image Systems, Inc. · Neurology device
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Mar 1991
Decision
315d
Days
Class 2
Risk

K901883 is an FDA 510(k) clearance for the STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stereotactic Image Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 7, 1991 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Stereotactic Image Systems, Inc. devices

FDA 510(k) Submission Details - K901883

510(k) Number K901883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date March 07, 1991
Days to Decision 315 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 148d · This submission: 315d
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 353
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K901883.
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
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AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
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COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd. · Aug 1986