Cleared Traditional

K946252 - STEREOPLAN

K946252 is an FDA 510(k) clearance for STEREOPLAN, manufactured by Radionics Software Applications, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K946252 · Radionics Software Applications, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
81d
Days
Class 2
Risk

K946252 is an FDA 510(k) clearance for the STEREOPLAN. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Radionics Software Applications, Inc. (Burlington, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 81 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 - K946252

510(k) Number K946252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date March 14, 1995
Days to Decision 81 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
68d faster than avg
Panel avg: 149d · This submission: 81d
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 K946252.
CRW-1 SYSTEM
K944463 · Radionics Software Applications, Inc. · Oct 1995
REGULUS MEASUREMENT UNIT
K935456 · Compass Intl., Inc. · Oct 1995
LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE
K946033 · Leibinger GmbH · Sep 1995
LEKSELL SURGIPLAN
K943468 · Elekta Instruments, Inc. · Jan 1995
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp. · Mar 1994
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · Nomos Corp. · Aug 1993
K946252 · STEREOPLAN
Download PDF FDA Summary Radionics Software Ap…