Cleared Special

K993763 - QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K993763 · Medis Medical Imaging Systems BV · Radiology device
Nov 1999
Decision
18d
Days
Class 2
Risk

K993763 is an FDA 510(k) clearance for the QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA). Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Medis Medical Imaging Systems BV (Ridgefield, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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.

Submission Details

510(k) Number K993763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date November 26, 1999
Days to Decision 18 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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.

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