Cleared Special

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900

K063029 · E-Z-Em, Inc. · Radiology
Nov 2006
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K063029 is an FDA 510(k) clearance for the EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on November 2, 2006, 31 days after receiving the submission on October 2, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K063029 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2006
Decision Date November 02, 2006
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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