Cleared Traditional

AEROSYNC FOR AERODR SYSTEM

K120477 · Konica Minolta Medical & Graphic, Inc. · Radiology
Apr 2012
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K120477 is an FDA 510(k) clearance for the AEROSYNC FOR AERODR SYSTEM, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Konica Minolta Medical & Graphic, Inc. (New York, US). The FDA issued a Cleared decision on April 9, 2012, 53 days after receiving the submission on February 16, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K120477 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2012
Decision Date April 09, 2012
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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