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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K880982
Device Name ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY
Applicant
Orion Corporation Soredex
Nilsiankatu 10-14
Helsinki,  FI FIN-00510
Applicant Contact ENSIO KOSKENNURMI
Correspondent
Orion Corporation Soredex
Nilsiankatu 10-14
Helsinki,  FI FIN-00510
Correspondent Contact ENSIO KOSKENNURMI
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/08/1988
Decision Date 06/06/1988
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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