Cleared Traditional

CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31

K003689 · Canon USA, Inc. · Radiology
Jan 2002
Decision
398d
Days
Class 2
Risk

About This 510(k) Submission

K003689 is an FDA 510(k) clearance for the CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31, a System, Imaging, X-ray, Electrostatic (Class II — Special Controls, product code IXK), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on January 2, 2002, 398 days after receiving the submission on November 30, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.

Submission Details

510(k) Number K003689 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2000
Decision Date January 02, 2002
Days to Decision 398 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXK — System, Imaging, X-ray, Electrostatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1630

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