Cleared Traditional

K984532 - CADPLAN HELIOS OPTION 6.0

K984532 is an FDA 510(k) clearance for CADPLAN HELIOS OPTION 6.0, manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K984532 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
231d
Days
Class 2
Risk

K984532 is an FDA 510(k) clearance for the CADPLAN HELIOS OPTION 6.0. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 9, 1999 after a review of 231 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 Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K984532

510(k) Number K984532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date August 09, 1999
Days to Decision 231 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
124d slower than avg
Panel avg: 107d · This submission: 231d
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 222
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K984532.
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
EXPLORER 3D
K991815 · Our Scientific Intl., Inc. · Aug 1999
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K983343 · Nucletron Corp. · Apr 1999
INTERPLANT
K982696 · Burdette Medical Systems, Inc. · Apr 1999
IMAGEFUSION 2.0
K990071 · Radionics, Inc. · Feb 1999