Cleared Traditional

K120477 - AEROSYNC FOR AERODR SYSTEM

K120477 is an FDA 510(k) clearance for AEROSYNC FOR AERODR SYSTEM, manufactured by Konica Minolta Medical & Graphic, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 53-day FDA review.

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

K120477 is an FDA 510(k) clearance for the AEROSYNC FOR AERODR SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Konica Minolta Medical & Graphic, Inc. (New York, US). The FDA issued a Cleared decision on April 9, 2012 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Konica Minolta Medical & Graphic, Inc. devices

FDA 510(k) Submission Details - K120477

510(k) Number K120477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 244
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K120477.
DX-D IMAGING PACKAGE
K121095 · Agfa Healthcare N.V. · Aug 2012
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K122182 · Rayence Co., Ltd. · Aug 2012
CR 10-X DIGITIZER
K121948 · Agfa Healthcare N.V. · Jul 2012
REGIUS SIGMA2
K120131 · Konica Minolta Medical & Graphic, Inc. · Feb 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630 · Rayence Co., Ltd. · Dec 2011
INFINIX-CCI
K113052 · Toshiba America Medical Systems, In.C · Nov 2011