Cleared Special

K111682 - DIGITAL RADIOGRAPHY

K111682 is an FDA 510(k) clearance for DIGITAL RADIOGRAPHY, manufactured by Canon Inc. -Medical Equipment Group. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 79-day FDA review.

K111682 · Canon Inc. -Medical Equipment Group · Radiology device
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Sep 2011
Decision
79d
Days
Class 2
Risk

K111682 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Canon Inc. -Medical Equipment Group (Tachikawa-Shi, Tokyo, JP). The FDA issued a Cleared decision on September 2, 2011 after a review of 79 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 Canon Inc. -Medical Equipment Group devices

FDA 510(k) Submission Details - K111682

510(k) Number K111682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2011
Decision Date September 02, 2011
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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 260
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K111682.
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630 · Rayence Co., Ltd. · Dec 2011
INFINIX-CCI
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WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · Fujifilm Medical System U.S.A., Inc. · Sep 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · Fujifilm Medical System U.S.A., Inc. · Aug 2011
REGUIS SIGMA
K103703 · Konica Minolta Medical & Graphic, Inc. · Jun 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · Fujifilm Medical Systems U.S.A, Inc. · Mar 2011