Cleared Traditional

RADIOTHERAPY SOLUTION BASED ON CR

K042779 · Agfa Corp. · Radiology
Oct 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K042779 is an FDA 510(k) clearance for the RADIOTHERAPY SOLUTION BASED ON CR, a System, Imaging, X-ray, Electrostatic (Class II — Special Controls, product code IXK), submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on October 21, 2004, 15 days after receiving the submission on October 6, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.

Submission Details

510(k) Number K042779 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2004
Decision Date October 21, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXK — System, Imaging, X-ray, Electrostatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1630

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