Cleared Traditional

ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) - FDA 510(k) Clearance

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

K033339 · Varian Medical Systems, Inc. · Radiology device
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Dec 2003
Decision
74d
Days
Class 2
Risk

K033339 is an FDA 510(k) clearance for the ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 30, 2003 after a review of 74 days - a notably fast clearance cycle.

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: 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 Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K033339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2003
Decision Date December 30, 2003
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K033339.
ADVANTAGE SIM MD
K052345 · Ge Healthcare · Sep 2005
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · Varian Medical Systems, Inc. · Jan 1997
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995