Cleared Traditional

K031633 - CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
(FDA 510(k) Clearance)

K031633 · Canon USA, Inc. · Radiology

Jun 2003

Decision

15d

Days

Class 2

Risk

K031633 is an FDA 510(k) clearance for the CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C. This device is classified as 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 June 11, 2003, 15 days after receiving the submission on May 27, 2003.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K031633 FDA.gov
FDA Decision	Cleared 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