Cleared Traditional

AERODR SYSTEM WITH P-31

K130936 · Konica Minolta Medical & Graphic, Inc. · Radiology
Aug 2013
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K130936 is an FDA 510(k) clearance for the AERODR SYSTEM WITH P-31, 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 August 22, 2013, 140 days after receiving the submission on April 4, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K130936 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2013
Decision Date August 22, 2013
Days to Decision 140 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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