Cleared Special

K092717 - DIRECT DIGITIZER

K092717 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 57-day FDA review.

K092717 · Konica Minolta Medical & Graphic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
57d
Days
Class 2
Risk

K092717 is an FDA 510(k) clearance for the DIRECT DIGITIZER, REGIUS MODEL 210. 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 October 30, 2009 after a review of 57 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 - K092717

510(k) Number K092717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2009
Decision Date October 30, 2009
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 K092717.
FLAT PANEL DETECTOR, MODEL FDR D-EVO
K100762 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · Fujifilm Medical System U.S.A., Inc. · Jan 2010
DX-D IMAGING PACKAGE
K092669 · Agfa Healthcare N.V. · Nov 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · Agfa Healthcare N.V. · Aug 2009
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · Canon, Inc. · Jun 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · Canon, Inc. · May 2009