Cleared Special

DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300

K032635 · Agfa Corp. · Radiology
Sep 2003
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K032635 is an FDA 510(k) clearance for the DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300, 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 24, 2003, 29 days after receiving the submission on August 26, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K032635 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2003
Decision Date September 24, 2003
Days to Decision 29 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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