Cleared Special

K120131 - REGIUS SIGMA2

K120131 is an FDA 510(k) clearance for REGIUS SIGMA2, manufactured by Konica Minolta Medical & Graphic, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 24-day FDA review.

K120131 · Konica Minolta Medical & Graphic, Inc. · Radiology device
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Feb 2012
Decision
24d
Days
Class 2
Risk

K120131 is an FDA 510(k) clearance for the REGIUS SIGMA2. 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 February 10, 2012 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Konica Minolta Medical & Graphic, Inc. devices

FDA 510(k) Submission Details - K120131

510(k) Number K120131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date February 10, 2012
Days to Decision 24 days
Submission Type Special
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
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K120131.
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K120477 · Konica Minolta Medical & Graphic, Inc. · Apr 2012
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INFINIX-CCI
K113052 · Toshiba America Medical Systems, In.C · Nov 2011
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K111865 · Fujifilm Medical System U.S.A., Inc. · Sep 2011