Cleared Special

K172793 - SKR 3000

K172793 is an FDA 510(k) clearance for SKR 3000, manufactured by Konica Minolta, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 27-day FDA review.

K172793 · Konica Minolta, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
27d
Days
Class 2
Risk

K172793 is an FDA 510(k) clearance for the SKR 3000. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on October 12, 2017 after a review of 27 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, Inc. devices

FDA 510(k) Submission Details - K172793

510(k) Number K172793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2017
Decision Date October 12, 2017
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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 Consultant

Storch Amini PC
Russell D. Munves

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 386
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K172793.
Galaxy R Digital Radiography Upgrade
K172435 · Medien International Co, Ltd. · Oct 2017
DX-D Imaging Package
K172784 · Agfa Healthcare N.V. · Oct 2017
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K171169 · Imaging Dynamics Company , Ltd. · Oct 2017
Edge Air Digital Flat Panel X-ray Detector
K172681 · Osko, Inc. · Oct 2017
Edge Digital Flat Panel X-ray Detector
K172682 · Osko, Inc. · Oct 2017
Aquarius 8600 1417WC
K171175 · Imaging Dynamics Company , Ltd. · Oct 2017