CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER— 510(k) K060440

Name: FDA 510(k) clearance K060440
Creator: U.S. Food and Drug Administration
Published: 2006-03-16

Substantially Equivalent

Codonics, Inc.

FDA 510(k) clearance K060440 for CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER, Substantially Equivalent on 2006-03-16. Applicant: Codonics, Inc.. Device class: 2.

Clearance details

Applicant: Codonics, Inc.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 2006-02-21
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Middleburg Heights, OH, US

Download summary PDF View on FDA.gov ↗

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