Cleared Special

LASER IMAGER DRYPRO MODEL 873

K081637 · Konica Minolta Medical & Graphic, Inc. · Radiology
Jul 2008
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K081637 is an FDA 510(k) clearance for the LASER IMAGER DRYPRO MODEL 873, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Konica Minolta Medical & Graphic, Inc. (New York, US). The FDA issued a Cleared decision on July 1, 2008, 20 days after receiving the submission on June 11, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K081637 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2008
Decision Date July 01, 2008
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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