Cleared Traditional

DRYSTAR, MODEL 4500M

K012941 · Agfa Corp. · Radiology
Nov 2001
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K012941 is an FDA 510(k) clearance for the DRYSTAR, MODEL 4500M, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Agfa Corp. (Rockville, US). The FDA issued a Cleared decision on November 29, 2001, 90 days after receiving the submission on August 31, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K012941 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2001
Decision Date November 29, 2001
Days to Decision 90 days
Submission Type Traditional
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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