Cleared Special

KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM

K060079 · Eastman Kodak Company · Radiology
Feb 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K060079 is an FDA 510(k) clearance for the KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on February 8, 2006, 29 days after receiving the submission on January 10, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K060079 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2006
Decision Date February 08, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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