Cleared Special

K023586 - DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

K023586 is an FDA 510(k) clearance for DR-ER VERFSION OF CANON X-RAY DIGITAL C..., manufactured by Canon USA, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 11-day FDA review.

K023586 · Canon USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
11d
Days
Class 2
Risk

K023586 is an FDA 510(k) clearance for the DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on November 5, 2002 after a review of 11 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.

FDA 510(k) Submission Details - K023586

510(k) Number K023586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2002
Decision Date November 05, 2002
Days to Decision 11 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
96d faster than avg
Panel avg: 107d · This submission: 11d
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K023586.
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K031447 · Canon, Inc. · May 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · Varian Medical Systems, Inc. · Feb 2003
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · Canon USA, Inc. · Nov 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · Konica Minolta Medical & Graphic, Inc. · Oct 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · Canon, Inc. · Oct 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · Eastman Kodak Company · Jul 2002
K023586 · DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
Download PDF FDA Summary Canon USA, Inc.