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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 K890351
Device Name ORTHORALIX SD/ORTHORALIX SD CEPH
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Applicant Contact WILLIAM G MCMAHON
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1740
Classification Product Code
IZF  
Date Received01/24/1989
Decision Date 06/15/1989
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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