Cleared Traditional

K013999 - LODOX, MODEL BASELINE

K013999 is an FDA 510(k) clearance for LODOX, manufactured by Lodox Systems (Pty), Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K013999 · Lodox Systems (Pty), Ltd. · Radiology device
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Aug 2002
Decision
245d
Days
Class 2
Risk

K013999 is an FDA 510(k) clearance for the LODOX, MODEL BASELINE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Lodox Systems (Pty), Ltd. (New York, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 245 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 Lodox Systems (Pty), Ltd. devices

FDA 510(k) Submission Details - K013999

510(k) Number K013999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date August 06, 2002
Days to Decision 245 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
138d slower than avg
Panel avg: 107d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 701
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