Cleared Traditional

K031633 - CANON INC.

K031633 is the FDA 510(k) clearance for CANON INC. by Canon USA, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K031633 · Canon USA, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
15d
Days
Class 2
Risk

K031633 is an FDA 510(k) clearance for the CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C. 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 June 11, 2003 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Canon USA, Inc. devices

Submission Details

510(k) Number K031633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date June 11, 2003
Days to Decision 15 days
Submission Type Traditional
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
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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.
PAMELA GWYNN

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 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K031633.
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FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · Fujifilm Medical System U.S.A., Inc. · Nov 2003
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