Cleared Special

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

K031571 · E-Z-Em, Inc. · Radiology
Jun 2003
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K031571 is an FDA 510(k) clearance for the EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825, a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on June 19, 2003, 30 days after receiving the submission on May 20, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K031571 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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