Cleared Traditional

K946128 - SIMULIX-HP

K946128 is an FDA 510(k) clearance for SIMULIX-HP, 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 148-day FDA review.

K946128 · Oldelft Corp. of America · Radiology device
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May 1995
Decision
148d
Days
Class 2
Risk

K946128 is an FDA 510(k) clearance for the SIMULIX-HP. 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 May 12, 1995 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oldelft Corp. of America devices

FDA 510(k) Submission Details - K946128

510(k) Number K946128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date May 12, 1995
Days to Decision 148 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
41d slower than avg
Panel avg: 107d · This submission: 148d
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 36
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K946128.
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838 · Toshiba America Medical Systems, In.C · Oct 1995
SIMVIEW(TM) 3000
K946053 · Siemens Medical Solutions USA, Inc. · Mar 1995
CMS RECORD AND VERIFY
K921108 · Computerized Medical Systems, Inc. · Nov 1992
ACQSIM SIMULATOR/LOCALIZER
K923851 · Philips Medical Systems (Cleveland), Inc. · Oct 1992