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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K945635
Device Name TRANS X-1000
Applicant
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Applicant Contact HIROYUKI TAKAHASHI
Correspondent
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Correspondent Contact HIROYUKI TAKAHASHI
Regulation Number892.1860
Classification Product Code
KPX  
Date Received11/16/1994
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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