Cleared Traditional

AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE

K023020 · Agfa Corp. · Radiology

Sep 2002

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K023020 is an FDA 510(k) clearance for the AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE, a Cassette, Radiographic Film (Class II — Special Controls, product code IXA), submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on September 26, 2002, 15 days after receiving the submission on September 11, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number	K023020 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2002
Decision Date	September 26, 2002
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF