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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K974877
Device Name CRANEX TOME CEPH, OR CRANEX TOME
Applicant
Orion Corporation Soredex
P.O. Box 79
Helsinki,  FI FIN-00511
Applicant Contact KAI LANER
Correspondent
Orion Corporation Soredex
P.O. Box 79
Helsinki,  FI FIN-00511
Correspondent Contact KAI LANER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/29/1997
Decision Date 03/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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