Cleared Special

K031571 - EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

K031571 is an FDA 510(k) clearance for EMPOWERCTA INJECTOR SYSTEM, manufactured by E-Z-Em, Inc.. The device is a Class 2 Radiology device with product code IZQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K031571 · E-Z-Em, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
30d
Days
Class 2
Risk

K031571 is an FDA 510(k) clearance for the EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on June 19, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1650 - 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.

FDA 510(k) Submission Details - K031571

510(k) Number K031571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date June 19, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 22
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K031571.
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · E-Z-Em, Inc. · Apr 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
K063090 · Medrad, Inc. · Mar 2007
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · Swiss Medical Care S.A. · Dec 2006
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
K983314 · Nycomed Amersham Imaging · Feb 1999
ACIST INJECTOR SYSTEM, MODEL CL100 H
K984058 · Acist Medical Systems · Feb 1999
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
K951005 · Kenex , Ltd. · May 1995
K031571 · EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
Download PDF FDA Summary E-Z-Em, Inc.