MODIFICATION TO LR 5200 FILM RECORDER— 510(k) K012010

Name: FDA 510(k) clearance K012010
Creator: U.S. Food and Drug Administration
Published: 2001-09-20

Substantially Equivalent

Agfa Corp.

FDA 510(k) clearance K012010 for MODIFICATION TO LR 5200 FILM RECORDER, Substantially Equivalent on 2001-09-20. Applicant: Agfa Corp.. Device class: 2.

Clearance details

Applicant: Agfa Corp.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 2001-06-27
Decision date: 2001-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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