Cleared Traditional

K180069 - HDR MRI Lumen Marker

K180069 is the FDA 510(k) clearance for HDR MRI Lumen Marker by C4 Imaging, LLC. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K180069 · C4 Imaging, LLC · Radiology device
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Apr 2018
Decision
108d
Days
Class 2
Risk

K180069 is an FDA 510(k) clearance for the HDR MRI Lumen Marker. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by C4 Imaging, LLC (Doylestown, US). The FDA issued a Cleared decision on April 27, 2018 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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

Submission Details

510(k) Number K180069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date April 27, 2018
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 97
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