Cleared Special

K071181 - DIRECT DIGITIZER

K071181 is an FDA 510(k) clearance for DIRECT DIGITIZER, 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 30-day FDA review.

K071181 · Konica Minolta Medical & Graphic, Inc. · Radiology device
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May 2007
Decision
30d
Days
Class 2
Risk

K071181 is an FDA 510(k) clearance for the DIRECT DIGITIZER, REGIUS MODEL 110. 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 May 30, 2007 after a review of 30 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 - K071181

510(k) Number K071181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date May 30, 2007
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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.

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All 244
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