Cleared Traditional

K993923 - ADAC PINNACLE3TM RADIATION THERAPY PLAN...

K993923 is the FDA 510(k) clearance for ADAC PINNACLE3TM RADIATION THERAPY PLAN... by Adac Laboratories. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K993923 · Adac Laboratories · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
141d
Days
Class 2
Risk

K993923 is an FDA 510(k) clearance for the ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on April 7, 2000 after a review of 141 days - within the typical 510(k) review window.

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 Adac Laboratories devices

Submission Details

510(k) Number K993923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1999
Decision Date April 07, 2000
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
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 130
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K993923.
BRAINSCAN
K994413 · Brainlab AG · Jul 2000
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000
PROTON VISION
K000922 · Varian Assoc., Inc. · May 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