Cleared Traditional

K131689 - MRI MARKER

K131689 is an FDA 510(k) clearance for MRI MARKER, manufactured by C4 Imaging, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K131689 · C4 Imaging, LLC · Radiology device
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Nov 2013
Decision
163d
Days
Class 2
Risk

K131689 is an FDA 510(k) clearance for the MRI MARKER. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by C4 Imaging, LLC (Bloomfield Hills, US). The FDA issued a Cleared decision on November 20, 2013 after a review of 163 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 C4 Imaging, LLC devices

FDA 510(k) Submission Details - K131689

510(k) Number K131689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date November 20, 2013
Days to Decision 163 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
56d slower than avg
Panel avg: 107d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 84
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K131689.
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CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
K132996 · Isoray, Inc. · Dec 2013
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K122704 · Best Medical Intl. · Jan 2013
RAPID STRAND RX
K122764 · Medi-Physics, Inc. · Dec 2012
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K113210 · Isoaid, LLC · Aug 2012