Cleared Traditional

K010682 - HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM

K010682 is an FDA 510(k) clearance for HELAX-TMS V 5.1 RADIATION THERAPY TREAT..., manufactured by Mds Nordion. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010682 · Mds Nordion · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
90d
Days
Class 2
Risk

K010682 is an FDA 510(k) clearance for the HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Mds Nordion (Ottawa, CA). The FDA issued a Cleared decision on June 5, 2001 after a review of 90 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 Mds Nordion devices

FDA 510(k) Submission Details - K010682

510(k) Number K010682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2001
Decision Date June 05, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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 176
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K010682.
ECLIPSE, HELIOS OPTION
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VARISEED 7.0
K012017 · Varian Medical Systems · Jul 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K010784 · Nucletron Corp. · Apr 2001
P3IMRT TM
K002237 · Adac Laboratories · Feb 2001
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · Brainlab AG · Nov 2000