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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, Tomographic
510(k) Number K884650
Device Name RESUBMITTED SCANORA
Applicant
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Applicant Contact ENSIO KOSKENNURMI
Correspondent
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Correspondent Contact ENSIO KOSKENNURMI
Regulation Number892.1740
Classification Product Code
IZF  
Date Received11/07/1988
Decision Date 03/16/1989
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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