Cleared Traditional

K062265 - CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM

K062265 is an FDA 510(k) clearance for CT EXPRES III CONTRAST MEDIA DELIVERY S..., manufactured by Swiss Medical Care S.A.. The device is a Class 2 Radiology device with product code IZQ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K062265 · Swiss Medical Care S.A. · Radiology device
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Dec 2006
Decision
144d
Days
Class 2
Risk

K062265 is an FDA 510(k) clearance for the CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Swiss Medical Care S.A. (Flemington, US). The FDA issued a Cleared decision on December 26, 2006 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1650 - 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 Swiss Medical Care S.A. devices

FDA 510(k) Submission Details - K062265

510(k) Number K062265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2006
Decision Date December 26, 2006
Days to Decision 144 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
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZQ Device Classification - Class 2, Special Controls

Product Code IZQ Injector, Contrast Medium, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - IZQ Injector, Contrast Medium, Automatic

All 17
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K062265.
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PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
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ACIST INJECTOR SYSTEM, MODEL CL100 H
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