Cleared Special

K042386 - DIRECT DIGITIZER

K042386 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 104-day FDA review.

K042386 · Konica Minolta Medical & Graphic, Inc. · Radiology device
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Dec 2004
Decision
104d
Days
Class 2
Risk

K042386 is an FDA 510(k) clearance for the DIRECT DIGITIZER, REGIUS MODEL 190. 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. (Watarai-Gun; Mie-Ken, JP). The FDA issued a Cleared decision on December 15, 2004 after a review of 104 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K042386

510(k) Number K042386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2004
Decision Date December 15, 2004
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
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
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