Cleared Traditional

K912466 - OLDELFT SIMULIX-MC

K912466 is an FDA 510(k) clearance for OLDELFT SIMULIX-MC, manufactured by Oldelft Corp. of America. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K912466 · Oldelft Corp. of America · Radiology device
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Jun 1991
Decision
24d
Days
Class 2
Risk

K912466 is an FDA 510(k) clearance for the OLDELFT SIMULIX-MC. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - the FDA radiology and imaging software oversight 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 - K912466

510(k) Number K912466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1991
Decision Date June 28, 1991
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 Radiology devices follow this clearance model.

Regulatory Peers - KPQ System, Simulation, Radiation Therapy

All 54
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K912466.
RAHD 3100
K903313 · Esm , Ltd. · Oct 1991
XIMATRON/CT OPTION
K910647 · Fischer Imaging Corp. · Sep 1991
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991
COMPUTE-RX-COMP (TM)
K910367 · Medicalibration Physics Consultant Services, Inc. · May 1991
CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT
K896555 · W. L. Systems, Inc. · Apr 1990
NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
K894568 · Advanced Medical Systems, Inc. · Jan 1990
K912466 · OLDELFT SIMULIX-MC
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