Cleared Special

DRYSTAR 5500

K023287 · Agfa Corp. · Radiology
Oct 2002
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K023287 is an FDA 510(k) clearance for the DRYSTAR 5500, 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 October 22, 2002, 20 days after receiving the submission on October 2, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K023287 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2002
Decision Date October 22, 2002
Days to Decision 20 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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