Cleared Traditional

K063090 - MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY

K063090 is an FDA 510(k) clearance for MEDRAD STELLANT CT INJECTOR SYSTEM WITH..., manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K063090 · Medrad, Inc. · Cardiovascular device
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Mar 2007
Decision
168d
Days
Class 2
Risk

K063090 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on March 27, 2007 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K063090

510(k) Number K063090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date March 27, 2007
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - IZQ Injector, Contrast Medium, Automatic

All 20
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K063090.
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CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · Swiss Medical Care S.A. · Dec 2006
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · E-Z-Em, Inc. · Jun 2003
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
K983314 · Nycomed Amersham Imaging · Feb 1999