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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 K851067
Device Name CANON X-RAY FILM CHANGER CFC-U1
Applicant
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact TAMADA
Correspondent
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Correspondent Contact TAMADA
Regulation Number892.1860
Classification Product Code
KPX  
Date Received03/18/1985
Decision Date 05/21/1985
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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