Cleared Special

AERODR SYSTEM WITH P-21 (K113248) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113248 · Konica Minolta Medical & Graphic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
75d
Days
Class 2
Risk

K113248 is an FDA 510(k) clearance for the AERODR SYSTEM WITH P-21. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Konica Minolta Medical & Graphic, Inc. (New York, US). The FDA issued a Cleared decision on January 17, 2012 after a review of 75 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

Submission Details

510(k) Number K113248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2011
Decision Date January 17, 2012
Days to Decision 75 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPR System, X-ray, Stationary
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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