Cleared Traditional

K992434 - ITP

K992434 is an FDA 510(k) clearance for ITP, manufactured by Nucletron Corp.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K992434 · Nucletron Corp. · Radiology device
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Jan 2000
Decision
176d
Days
Class 2
Risk

K992434 is an FDA 510(k) clearance for the ITP, MODEL 1.0. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 176 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Nucletron Corp. devices

FDA 510(k) Submission Details - K992434

510(k) Number K992434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1999
Decision Date January 13, 2000
Days to Decision 176 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 107d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 136
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K992434.
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K993923 · Adac Laboratories · Apr 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · Nucletron Corp. · Mar 2000
BRACHYVISION 6.0
K992762 · Varian Assoc., Inc. · Mar 2000
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · Varian Assoc., Inc. · Sep 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · Radionics, Inc. · Aug 1999
CADPLAN HELIOS OPTION 6.0
K984532 · Varian Medical Systems, Inc. · Aug 1999