Cleared Traditional

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K032724) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032724 · Adac Laboratories · Radiology device
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Oct 2003
Decision
36d
Days
Class 2
Risk

K032724 is an FDA 510(k) clearance for the PINNACLE3 RADIATION THERAPY PLANNING SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Adac Laboratories (Madison, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adac Laboratories devices

Submission Details

510(k) Number K032724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2003
Decision Date October 09, 2003
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 106
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K032724.
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