Cleared Traditional

K083414 - RADIONICS XKNIFE HDRT SYSTEM

K083414 is an FDA 510(k) clearance for RADIONICS XKNIFE HDRT SYSTEM, manufactured by Integra Radionics, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K083414 · Integra Radionics, Inc. · Radiology device
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Mar 2009
Decision
104d
Days
Class 2
Risk

K083414 is an FDA 510(k) clearance for the RADIONICS XKNIFE HDRT SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Integra Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on March 2, 2009 after a review of 104 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 Integra Radionics, Inc. devices

FDA 510(k) Submission Details - K083414

510(k) Number K083414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2008
Decision Date March 02, 2009
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
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 K083414.
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K082606 · D3 Radiation Planning · Nov 2008
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K082642 · Nucletron Corporation · Nov 2008