Cleared Traditional

K062386 - QANGIO CT (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062386 · Medis Medical Imaging Systems BV · Radiology device
Oct 2006
Decision
51d
Days
Class 2
Risk

K062386 is an FDA 510(k) clearance for the QANGIO CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Medis Medical Imaging Systems BV (Leiden, NL). The FDA issued a Cleared decision on October 5, 2006 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment — the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K062386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2006
Decision Date October 05, 2006
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
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 88
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