Cleared Special

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM

K041701 · Agfa Corp. · Radiology
Jul 2004
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K041701 is an FDA 510(k) clearance for the AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on July 22, 2004, 30 days after receiving the submission on June 22, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K041701 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2004
Decision Date July 22, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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