Cleared Traditional

CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 (K992547) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992547 · Canon USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
75d
Days
Class 2
Risk

K992547 is an FDA 510(k) clearance for the CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22. 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 October 13, 1999 after a review of 75 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 K992547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date October 13, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 142
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K992547.
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · Varian Medical Systems, Inc. · Feb 2003
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · Eastman Kodak Company · Jul 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635 · Eastman Kodak Company · Mar 2002
THORAX FD AND MULTIX FD
K983732 · Siemens Medical Solutions USA, Inc. · Apr 1999