AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE— 510(k) K023020

Name: FDA 510(k) clearance K023020
Creator: U.S. Food and Drug Administration
Published: 2002-09-26

Substantially Equivalent

Agfa Corp.

FDA 510(k) clearance K023020 for AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE, Substantially Equivalent on 2002-09-26. Applicant: Agfa Corp.. Device class: 2.

Clearance details

Applicant: Agfa Corp.
Product code: Code IXA
Device class: Class 2
Regulation: 21 CFR 892.1850
Advisory panel: Radiology
Date received: 2002-09-11
Decision date: 2002-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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