Cleared Traditional

K022326 - RADIOMED MARKER

K022326 is the FDA 510(k) clearance for RADIOMED MARKER by Radiomed Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K022326 · Radiomed Corporation · Radiology device
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Jan 2003
Decision
197d
Days
Class 2
Risk

K022326 is an FDA 510(k) clearance for the RADIOMED MARKER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Radiomed Corporation (Tyngsboro, US). The FDA issued a Cleared decision on January 31, 2003 after a review of 197 days - an extended review cycle.

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

Submission Details

510(k) Number K022326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2002
Decision Date January 31, 2003
Days to Decision 197 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 592
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K022326.
CARD EP
K031261 · GE Medical Systems · May 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · GE Medical Systems · Mar 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · Philips Medical Systems (Cleveland), Inc. · Feb 2003
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · Toshiba America Medical Systems, In.C · Nov 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · GE Medical Systems · Oct 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · GE Medical Systems · Sep 2002