Cleared Special

MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

K071378 · E-Z-Em, Inc. · Radiology
Jun 2007
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K071378 is an FDA 510(k) clearance for the MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES, 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 June 13, 2007, 27 days after receiving the submission on May 17, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K071378 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2007
Decision Date June 13, 2007
Days to Decision 27 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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