Cleared Special

XPLAN 2.2 WITH THE BODY SYSTEM (K013661) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013661 · Radionics, A Division of Tyco Healthcare Group LP · Radiology device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
27d
Days
Class 2
Risk

K013661 is an FDA 510(k) clearance for the XPLAN 2.2 WITH THE BODY SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Radionics, A Division of Tyco Healthcare Group LP (Burlington, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 27 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 Radionics, A Division of Tyco Healthcare Group LP devices

Submission Details

510(k) Number K013661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date December 03, 2001
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 106
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K013661.
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