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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K052682
Device Name ALIGNRT
Applicant
VISION RT LIMITED
DAWS HOUSE,33-35 DAWS LANE
LONDON,  GB NW7 4SD
Applicant Contact NORMAN SMITH
Correspondent
INTERTEK TESTING SERVICES
70 CODMAN HILL RD.
BOXBOROUGH,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/28/2005
Decision Date 01/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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