Cleared Special

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

K000159 · Agfa Corp. · Radiology
Feb 2000
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K000159 is an FDA 510(k) clearance for the AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO, 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 February 16, 2000, 28 days after receiving the submission on January 19, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.

Submission Details

510(k) Number K000159 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2000
Decision Date February 16, 2000
Days to Decision 28 days
Submission Type Special
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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