KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)— 510(k) K931551

Name: FDA 510(k) clearance K931551
Creator: U.S. Food and Drug Administration
Published: 1993-06-29

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K931551 for KODAK EKTASCAN IMAGELINK SYSTEM (KEIS), Substantially Equivalent on 1993-06-29. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1993-03-29
Decision date: 1993-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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