Cleared Special

K031206 - RADIOMED SOFT TISSUE MARKER

K031206 is an FDA 510(k) clearance for RADIOMED SOFT TISSUE MARKER, manufactured by Radiomed Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 35-day FDA review.

K031206 · Radiomed Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
35d
Days
Class 2
Risk

K031206 is an FDA 510(k) clearance for the RADIOMED SOFT TISSUE MARKER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Radiomed Corp. (Tyngsboro, US). The FDA issued a Cleared decision on May 21, 2003 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Radiomed Corp. devices

FDA 510(k) Submission Details - K031206

510(k) Number K031206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2003
Decision Date May 21, 2003
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 696
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