Cleared Traditional

K993923 - ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM

K993923 is an FDA 510(k) clearance for ADAC PINNACLE3TM RADIATION THERAPY PLAN..., manufactured by Adac Laboratories. The device is a Class 2 Radiology device with 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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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

FDA 510(k) Submission Details - K993923

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.

MUJ Device Classification - Class 2, Special Controls

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 213
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K993923.
XPLAN 2.1
K001700 · Radionics, Inc. · Jun 2000
OPTIRAD
K993895 · Permedics, Inc. · Jun 2000
PROTON VISION
K000922 · Varian Assoc., Inc. · May 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
ITP, MODEL 1.0
K992434 · Nucletron Corp. · Jan 2000