Cleared Special

LR DICOM CONTROLLER

K022658 · Agfa Corp. · Radiology
Sep 2002
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K022658 is an FDA 510(k) clearance for the LR DICOM CONTROLLER, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on September 6, 2002, 28 days after receiving the submission on August 9, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K022658 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2002
Decision Date September 06, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LMC — Camera, Multi Format, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2040

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