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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K854085
Device Name OMNI PLANE SYSTEM
Applicant
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Applicant Contact DONNA GLENCROSS
Correspondent
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact DONNA GLENCROSS
Regulation Number892.1980
Classification Product Code
IXR  
Date Received10/07/1985
Decision Date 10/28/1985
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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