Cleared Traditional

CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G

K023750 · Canon USA, Inc. · Radiology
Nov 2002
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K023750 is an FDA 510(k) clearance for the CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on November 22, 2002, 14 days after receiving the submission on November 8, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K023750 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2002
Decision Date November 22, 2002
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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