Cleared Traditional

K020971 - DCM 2.0

K020971 is an FDA 510(k) clearance for DCM 2.0, manufactured by Mds Nordion AB. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K020971 · Mds Nordion AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
72d
Days
Class 2
Risk

K020971 is an FDA 510(k) clearance for the DCM 2.0. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Mds Nordion AB (Ottawa, CA). The FDA issued a Cleared decision on June 6, 2002 after a review of 72 days - a notably fast clearance 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: 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 Mds Nordion AB devices

FDA 510(k) Submission Details - K020971

510(k) Number K020971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2002
Decision Date June 06, 2002
Days to Decision 72 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
35d faster than avg
Panel avg: 107d · This submission: 72d
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 204
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K020971.
SPOT PRO (220V), MODEL 131.099
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VARISEED 7.0
K012017 · Varian Medical Systems · Jul 2001