Cleared Special

K023124 - CANON X-RAY DIGITAL CAMERA WITH ADDITIO...

K023124 is an FDA 510(k) clearance for CANON X-RAY DIGITAL CAMERA WITH ADDITIO..., manufactured by Canon, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 15-day FDA review.

K023124 · Canon, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 2002
Decision
15d
Days
Class 2
Risk

K023124 is an FDA 510(k) clearance for the CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Canon, Inc. (Ohta-Ku, Tokyo, Japan, JP). The FDA issued a Cleared decision on October 4, 2002 after a review of 15 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. devices

FDA 510(k) Submission Details - K023124

510(k) Number K023124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2002
Decision Date October 04, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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

Underwriters Laboratories, Inc.

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 244
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K023124.
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