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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K023124
Device Name CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
Applicant
Canon, Inc.
30-2 Shimomaruko 3-Chome
Ohta-Ku, Tokyo, Japan,  JP 146
Applicant Contact SHIELA DRISCOLL
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/19/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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