Cleared Special

K011246 - DCM 1.0

K011246 is an FDA 510(k) clearance for DCM 1.0, manufactured by Mds Nordion. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K011246 · Mds Nordion · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
30d
Days
Class 2
Risk

K011246 is an FDA 510(k) clearance for the DCM 1.0. 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 May 23, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mds Nordion devices

FDA 510(k) Submission Details - K011246

510(k) Number K011246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date May 23, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K011246.
ECLIPSE, HELIOS OPTION
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PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K010784 · Nucletron Corp. · Apr 2001
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K002237 · Adac Laboratories · Feb 2001
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · Brainlab AG · Nov 2000