Cleared Special

KODAK ECLIPSE IMAGE PROCESSING SOFTWARE

K060137 · Eastman Kodak Company · Radiology
Mar 2006
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K060137 is an FDA 510(k) clearance for the KODAK ECLIPSE IMAGE PROCESSING SOFTWARE, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 16, 2006, 56 days after receiving the submission on January 19, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K060137 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2006
Decision Date March 16, 2006
Days to Decision 56 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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