Cleared Traditional

K091435 - DIGITAL RADIOGRAPHY MODEL CXDI-55G

K091435 is the FDA 510(k) clearance for DIGITAL RADIOGRAPHY MODEL CXDI-55G by Canon, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K091435 · Canon, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
May 2009
Decision
15d
Days
Class 2
Risk

K091435 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY MODEL CXDI-55G. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Canon, Inc. (Lake Success, US). The FDA issued a Cleared decision on May 29, 2009 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, Inc. devices

Submission Details

510(k) Number K091435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2009
Decision Date May 29, 2009
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.
JEFF D RONGERO

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 K091435.
FLAT PANEL DETECTOR, MODEL FDR D-EVO
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K093427 · Fujifilm Medical System U.S.A., Inc. · Jan 2010
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · Canon, Inc. · Jun 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436 · Canon, Inc. · May 2009
CARESTREAM DRX-1 SYSTEM
K090318 · Carestream Health, Inc. · Apr 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623 · Canon USA, Inc. · Mar 2009